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WuXi Biologics Ireland Limited
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  • Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: The Delta V Lead - Permanent Contract opportunity The Delta V Lead will be responsible for the site DeltaV systems and will support complex and challenging initiatives, develop automation strategies, plan and execute system roadmaps and support new technology deployment in alignment with Corporate platform leads. The Delta V Lead will work closely with multiple disciplines, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements. Department Description As a Delta V Lead youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. This role will report the AIS Associate Director. Your Responsibilities Provide system administration and ownership support for Delta V and Utility systems. Support includes: Infrastructure and networking architecture User Access Patching, Security and Compliance Optimal performance for Delta V control system (software/hardware) reliability End-User interface Provide technical support to commercial and clinical manufacturing as needed, specific to process control and automation infrastructure. Lead technical root cause analysis, incident investigations and troubleshooting issues related to electrical, instrumentation and equipment control systems Develop, organize, analyse, and present results for operational issues and projects of moderate scope and complexity. Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures Support new product introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs Communicate proactively with supervisor and support staff, highlighting issues and proposing solutions. Manage and maintain software system licenses and support/maintenance contract renewals. Apply software updates, patches, and hot-fixes as required to keep automation engineering computer systems running efficiently with minimal downtime. System owner responsibilities such as change control, maintenance, backup/restore and disaster recovery and regulatory compliance. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations Perform all duties in accordance with GMP requirements, SOPs and controlled documents Flexibility to take on additional tasks and responsibilities at the discretion of the AIS Associate Director. Will act as a role model for the Engineering function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile The ideal candidate for this position, will have the following: Education Bachelors in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering Knowledge/Experience: Required: Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation. Minimum of 8 years experience in automation engineering in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries. Direct hands on experience with lifecycle management of DeltaV software, hardware and infrastructure with extensive understanding and background in design, programming and installation Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services. Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems. Strong process control systems automation background. Strong network architecture or engineering proficiencies including TCP/IP, Routing Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls Experience with Tech Transfer, Process Design, and Commissioning Experience with validation and change control methodology Experienced in change control, non-conformance, corrective and preventative actions, and validation practices. Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. In-depth knowledge in programing language (e.g. VBA). Familiarity with OSI PI Historian. Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering context. Preferred: Knowledge of ASTM 2500, ISA S88 and S95 techniques. - Batch processing a desired advantage. Personal skills: Required: Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans Ability to constructively challenge, defend and present technical aspects of system design Ability to influence the development of business area strategy and AIS strategy where appropriate Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration Excellent communication, interpersonal and presentation skills. Collaborative and inclusive approach to work and your colleagues. Excellent problem solving and troubleshooting skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Autonomous and a self-starter who will use their initiative to drive actions forward. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer Skills: DeltaV lifecycle management process control systems automation network architecture and engineering validation and change control methodologies OSI PI Historian proficiency. Benefits: Bonus Educational assistance Life Assurance Pension VHI

  • Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As Manufacturing Systems Specialist, you will be responsible for establishing the Manufacturing Systems team within the Manufacturing Operations group. The incumbent will provide expert support to the manufacturing team in the areas of SAP, LIMS, finite scheduling (Orchestrate) and benchtop equipment. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We provide our clients with a world-leading open access technology platform and enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. Department Description As Manufacturing Systems Specialist, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will be reporting to the Manufacturing Systems Lead. Your Responsibilities In this role, you will be a key member of Manufacturing Operations team in WuXi Biologics Ireland. Provide expert support to the Manufacturing department in the areas of SAP, LIMS, Trackwise and Finite Scheduling. Process and System owner for Manufacturing benchtop equipment. Responsibilities in this area will include but are not limited to management of the MFG benchtop support e.g., vendors, maintain an accurate equipment list of benchtop equipment and ensure all required system SOPs are in place. Ensure all Manufacturing benchtop equipment are maintained in a qualified state by collaborating with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning). Co-ordinate vendor visits on site for bench top support, qualification and maintenance as needed. Provide input to budget for systems. Collaborate with MT and MSAT groups on technical transfer and process validation as required. Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections. Ensure that the MFG training team are supported regarding benchtop equipment training and troubleshooting as needed. Ensuring continual improvement of manufacturing documentation (SOPs MBRs, OJTs) for areas of responsibility to ensure they are current, accurate, and clear. Communicate operational status regularly to senior management, as required, at the appropriate level of detail. Assist the MFG systems lead to coordinate the work between theMFG systemsgroups and other functional groups to meet the production objectives and timelines. Responsible for identifying and assessing new models of benchtop and new equipment as required. Will be flexible to take on additional tasks and responsibilities at the discretion of theManufacturing Operations Associate Director and Systems lead. Support future initiatives such as electronic batch records, electronic logbooks, etc. on behalf of Manufacturing. Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile:The ideal candidate for this position, will have the following: Education Diploma, BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science Knowledge/Experience Required: More than 2 years in biopharmaceutical manufacturing. Experience with GMP systems such as SAP and Benchtop equipment qualification and operation etc. Ideally have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. Experience in working with the cross-functional teams. Strong team lead with the demonstrated ability to manage and support manufacturing operations in a flexible and dynamic team environment. A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant. The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification). Knowledge of GMP systems such as SAP and Benchtop equipment qualification and operation etc. Ideally knowledge and experience of scheduling software including Orchestrate. Personal skills Required: Ideally, experienced in establishing a Manufacturing department and working in a team in a greenfield context of similar size and scale. A strong collaborator with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports. Excellent verbal and written communication and presentation skills. Excellent people skills with the ability to work effectively with staff at all levels of the organisation. Ability to work on own initiative and be initiative-taking. Results oriented, with the ability to manage multiple priorities in a short period of time. Excellent organizational and planning skills and strong diligence As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment, dont miss out on this opportunity to join us. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: IT Networking Analytical Team Collaboration CGMP Benefits: Bonus Canteen Parking Pension VHI

  • AIS Applications Lead  

    - Dundalk

    Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As an AIS Applications Lead you will be responsible for effectively managing and leading the IS Applications, Analytics and Laboratory IT support teams, supporting site operations and promoting a culture of continuous improvement. The AIS Applications Lead will champion the use of data and information, play a key role identifying where, when, how and why the business uses data, and transform it into information that serves each function at the site. This role will report to the Automation Lead Associate Director Essential Duties and Responsibilities Lead and provide technical guidance to the IS Applications support team and the Laboratory IT support team, ensuring the necessary resources and skill sets are available and developed to meet current and future business needs Develop IS strategies, plan and execute system roadmaps and support new technology deployment Increase and maintain site Historian data collection to support existing manufacturing areas and new projects. Deliver and present analytics / reports for key stakeholders across the site to drive decision making - champion the use of data and information evolving WuXi Dundalk into a true data-driven organization Responsible for determining the sites data related needs and developing proposed solutions. Responsible for the maintenance, administration, compliance and availability of the application systems and Laboratory IT systems. Management of 3rd party suppliers/contractors/Systems integrators as required Technical solution design and evaluation, delivery, commissioning and validation, schedule tracking, budget management for sustaining initiatives Evolution and continuous improvement of work processes to ensure consistency, efficiency and quality, employing LEAN practices as appropriate Definition and maintenance of clear metrics to demonstrate team performance and service delivery Ensure appropriate and timely escalation of issues and risks Ensuring alignment of solutions with WuXi and industry standards and regulations as they pertain to systems and system architectures Active member of the AIS management team, contributing to and supporting the overall AIS strategy and functional deliverables Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and WuXi requirements, policies and procedures Be a champion for safe working practices and safety initiatives within their functional area and beyond Travel at various times is anticipated to support AIS and Operations network alignment, knowledge share and projects. Will be flexible to take on additional tasks and responsibilities at the discretion of the Site Lead and Vice President (or whoever the manager is.) Will act as a role model for the Engineering function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Person Specification Technical Competencies Strong knowledge of databases, reporting and analytic systems and Information Systems supporting manufacturing business unit is a plus. Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information. Experience Strong level of demonstrated experience in operations/manufacturing environment leading teams Experience in the delivery and management of GMP AIS Application systems such as OSI Pi Historian, TrackWise, Maximo, Document Management Systems etc. and GMP Laboratory IT Systems such as Empower CDS, LMES, Sample Manager LIMS, Laboratory Analytical Equipment and instruments will be an advantage. Experience dealing with a large portfolio of systems, projects and initiatives in the areas of Information Systems and Operations. Experience and ability to constructively challenge and present technical aspects of system design Qualifications Bachelors in Electrical Engineering or Computer Science, Biotech Engineering or related computer science engineering is ideal Behavioural Competencies Strong communication and presentation skills. Excellent organisation skills with ability to manage own work. Must be able to work with a variety of teams, made up of both technical and non-technical personnel. Coaching and facilitation skills An ability to work through peers and across organizational boundaries and influence at all levels in the business As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you can thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at WuXi Biologics is an equal opportunities employer Skills: GMP AIS Applications OSI Pi Historian TrackWise Maximo Laboratory IT Systems Data Analytics System Validation Benefits: Bonus Life Assurance Pension VHI

  • Delta V Engineer  

    - Dundalk

    Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As a Delta V Engineer, youwill have responsibility for systems within the site Delta V systems and will support complex and challenging initiatives, develop automation strategies, plan, and execute system roadmaps and support new technology deployment in alignment with platform leads. The Individual will work closely with multiple disciplines, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia, and Ireland. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As Delta V Engineeryoull be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the AIS Team Lead. Your Responsibilities In this role, youwillProvide ownership and support for Delta V systems. Support includes: Act as System Owner for Process Automation Equipment Troubleshoot and complete Root Cause analysis of automation issues. Compliance Optimization of code and system strategies to improve system (software/hardware) reliability. Interface configuration Provide technical support to commercial and clinical manufacturing as needed, specific to process control and automation configuration. Lead technical root cause analysis, incident investigations and troubleshooting issues related to electrical, instrumentation and equipment control systems. Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures Support new product introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering runs. Communicate proactively with supervisor and support staff, highlighting issues and proposing solutions. System owner responsibilities such as change control, maintenance, and regulatory compliance. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations. Perform all duties in accordance with GMP requirements, SOPs, and controlleddocuments. Flexibility to take on additional tasks and responsibilities at the discretion of the AIS Team Lead. Will act as a role model for the Engineering function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile The ideal candidate for this position, will have the following: Education Bachelors in electrical engineering or computer science, Chemical Engineering, Biotech Engineering, or related life science engineering. Knowledge/Experience Minimum of 5 years experience automation engineering in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries. Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services. Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems. Experience with Tech Transfer, Process Design, and Commissioning Experience with validation and change control methodology. Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. In-depth knowledge of programming language (e.g. VBA). Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering context. Knowledge of ASTM 2500, ISA S88 and S95 techniques. - Batch processing a desired advantage. Strong process control systems automation background. Personal skills Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Excellent communication, interpersonal and presentation skills. Collaborative and inclusive approach to work and your colleagues. Excellent problem solving and troubleshooting skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Autonomous and a self-starter who will use their initiative to drive actions forward. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you can thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at WuXi Biologics is an equal opportunities employer. Skills: Delta V Protein Purification Media and Buffer Preparation Clean Utilities Benefits: Bonus Educational assistance Pension Sports & Social Club VHI

  • Bioprocess Associate  

    - Dundalk

    Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As an experienced Bioprocess Associate you will be responsible for working with the wider Manufacturing teams to support the production of biological products at the Dundalk facility. This role will be responsible for procedures and processes associated with the manufacture of commercial large-scale Drug Substance. Department Description As Bioprocess Associate, you will be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will be reporting to the Shift Lead. Your Responsibilities In this role, you will Assist in maintaining a safety orientated Culture, cGMP compliant work environment always. Where necessary assist in Facility and Equipment start-up and Validation activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products. Assist as a member of the Production team, towards the delivery of production output targets and quality levels on schedule. Carry out all production operations in the assigned area as directed by the relevant Standard Operating Procedures and Manufacturing Batch Records. Perform initial troubleshooting of issues identified during routine operations. Take part in investigations and optimization of processes using scientific, engineering, and lean principles. Training and mentoring of colleagues in SOPs, process execution and equipment operation. Write, review and revision of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions Seek opportunities for Continuous Improvement using Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.) Immediately notify the Shift Lead or Senior Team Member of any deviation from SOPs and/or deviations in the standard production process Perform housekeeping duties as assigned to maintain facility at a high standard. Complete all training in a timely manner. Maintain assigned training always ensuring full compliance. Adhere fully to all safety policies, procedures, and regulations. Ensure highest Quality & Compliance standards. Perform all duties in accordance with GMP requirements, SOPs, and controlled documents. Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Shift Lead Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile The ideal candidate for this position, will have the following: Education A Certificate, Diploma, Degree, or equivalent qualification in Science, Engineering, or a related field is essential. This includes disciplines such as Biopharmaceutical Science, Pharmaceutical Science, or similar. Knowledge/Experience Required: 0-3 years experience in biopharmaceutical or pharmaceutical cGMP manufacturing required Experienced in the Manufacturing function in a greenfield context of similar size and scale is an advantage. Thorough knowledge of current Good Manufacturing Practices (GMP) is required Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs. Technical Competencies Technical knowledge of bioprocessing/biotechnology and Upstream and /or Downstream biologics processes is required. Ability to work within and adapt to complex electronic systems such process automation, SAP and Trackwise investigation system. Must be familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, media/buffer systems, and purification systems. Personal skills Required: Excellent communication, interpersonal and presentation skills. Collaborative and inclusive approach to work and your colleagues. Excellent problem solving and troubleshooting skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Autonomous and a self-starter who will use their initiative to drive actions forward. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you can thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. We offer: At WuXi Biologics, we offer a wide range of benefits to our employees, including exclusive discounts across various sectors such as retail, restaurants, hotels, and education. Additional benefits include: Education Assistance Annual Bonus Pension Scheme Healthcare Life Assurance Access to Social Committees These benefits reflect our commitment to supporting the well-being and growth of our team. Skills: Biopharmaceutical manufacturing cGMP compliance Bioprocessing Upstream processing Downstream processing Bioreactors Process automation Benefits: Bonus Educational assistance Laptop Life Assurance Pension Sports & Social Club VHI

  • Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: QA NPI Technical Lead Associate Director We are seeking a highly skilled QA Technical Lead to join our team. In this role you will ensure that new products meet quality standards, client expectations and regulatory requirements by overseeing the Quality Strategy throughout the NPI lifecycle. This will be achieved by ensuring: Compliance driven decisions are executed throughout the New Product Introduction lifecycle. Risk Identification and Mitigation: Identify and mitigate New Product/Process Quality and Compliance Risks. Adherence to Standards: Ensure all NPI and related activities are executed in accordance with site/corporate SOPs, cGMP, CMC regulatory and client requirements. Communications and Management: Formally manage communications between Client and WuXi. Support Investigations: Support Product/Process Quality Investigations, Deviations and Capas as required. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global clients in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU and Asia. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies. Department Description As QA Technical Lead youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. Your Responsibilities In this role, youwill carry out essential duties. Leading QA oversight of all New Product Introduction, Technology Transfer and Product Continual Improvement teams, to ensure compliance to SOPs, cGMP and CMC regulatory requirements as well as acting as a Quality advocate for consistency and harmonisation across specifications, analytical methods, and manufacturing processes. Be the technical lead between local QA, QC, QPs and the Client for product quality investigations, deviations, CAPAs and Master batch record review. Lead Quality role in the Technology Transfer for products to WuXi Biologics facility. Be the lead QA reviewer/approver of Technology Transfer and post-approval change documentation, including but not limited to TTMP, PD, sampling plan, BOMs, MBRs, etc., to ensure compliance withcGMPs, CMC Regulatory and Client requirements. Execute a leadership role with Quality colleagues and other stakeholders on product quality investigations, critically assess and challenge impact assessments for effectivity and compliance to applicable regulatory requirements. Play a significant role in the formal review and approval of gap assessments and/or comparability reports tofacilitaterelease of pre-approval PPQ batches following receipt of regulatory dossier/variation approval. Prepare APQRs for the products manufactured by WuXi Biologics Ireland, manage with the individual section authors and with the Client reviewer/approver, raise CAPAs, as required, and track to closure. Collaborate with the Client QualityLeadto ensure that the requirements of the Client Quality Agreements are met, including maintenance of supply chain maps and communication of changes and quality events to the Clientin a timely manner. If required, perform quality review of CMC sections of regulatory submissions and responses to queries. Facilitate management and closure of post-marketing regulatory commitments through the site change control system. To support site audit ready status, lead the QA technical function toensure full compliance at all times. Take a leadership role in coaching and mentoring cross functions in the technical analysis and requirements to ensure compliance and improved impact assessments.Drive and lead rightfirst-time culture within the organisationregardingtechnical review and implementation. Your Profile: The ideal candidate for this position, will have the following: Qualifications: Advanced degree (Bachelor,Master, or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, orotherrelated fields. Knowledge/Experience: At least 10 years relevant work experience in BioPharma industry, preferably Validation, Quality or MSAT roles. Must be familiar with EMA & FDA regulations; ICH and WHO guidelines Preferable knowledge of CMC stage gates and submission types. Behavioural Competencies Proven ability to lead projects and inspire cross functional teams. Effective at managing and influencing stakeholders. Demonstrated Problem Solving with growth mindset. Strong communicationskills withdemonstratedability to work in a matrix environment. Strong analytical skills. Strong decision maker based on risk level is a key competency of this role. Result and solution focused. Strategic thinker with drive for business continuous improvement and customer focused. Other Requirements Must be willing to travel as required internationally to fulfil the responsibilities of the position. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission -Any drug can be made, and any disease can be treated- dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! WuXi Biologics is an equal opportunities employer. Would you like to know more before you apply? Please visit us ator contact us via Skills: NPI Leadership Quality Product Release Analytical Benefits: Bonus Parking Pension Sports & Social Club VHI

  • Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Manufacturing Director This position is the lead role for the MFG 7 Batch-Fed Single Use facility in the Manufacturing Department of the WuXi Biologics Manufacturing Organisation. The role is an integral part of the Manufacturing Department, responsible initially for the establishment of the MFG 7 facility during construction and commissioning and latterly the long-term leadership to ensure all customer requirements are delivered on time and in full. The MFG 7 Lead is responsible for building the MFG 7 Upstream and Downstream Teams in addition to the Manufacturing Technology technical group. The role is a critical leadership role on site requiring close collaboration with all functions on site. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia, and Ireland. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As Manufacturing Director you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report into the Senior Manufacturing Director. Your Responsibilities Key member of Manufacturing leadership team for WuXi Biologics Ireland. The incumbent will play an important role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution. The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site Manufacturing organisation. Support the development of the overall Manufacturing strategy aligned with the facilitys strategic business plans and global Manufacturing strategy. Build the newly formed MFG 7 Organisation in Dundalk establishing clear team identity, roles, responsibilities, and hand-over with other functions. Supervisor to the MFG 7 Upstream Lead, MFG 7 Downstream Lead, MFG 7 Innoculation Lab and Cell Bank Lead and the MFG 7 Manufacturing Technology Lead. Provide oversight of the design, construction, and qualification of the MFG 7 facility in Dundalk. Serve as MFG 7 drug substance (inclusive of Upstream cell culture and Downstream purification) process subject matter expert, providing technical oversight to teams, and coaching to associate staff. Technical Point of Contact for customers in relation to MFG 7. Providing technical and commercial leadership of: Oversight of day-to-day Upstream and Downstream manufacturing activities ensuring production timelines are met. Collaboration with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections. All MFG 7 product quality related investigations and corrective or preventative action. Equipment, Facility and Documentation Changes within the facility. Collaboration with MSAT, Process Development and Project Management groups on technical transfer and process validation. New Product Implementation, including scale-up, through technology/process transfer to clinical and commercial manufacturing. Providing technical input to manufacturing process validation plans, protocols, and reports. Supporting all RFP business requests with required facility fits and technical information. Ensuring continual improvement of all manufacturing documentation (SOPs MBRs, OJTs) to ensure they are current, accurate, and clear. Communicate operational status regularly to senior management, as required, at the appropriate level of detail. Collaborate closely to assist the Senior Manufacturing Director in coordinating the work between the MFG 7 group and other functional groups to meet the production objectives and timelines. Authoring and reviewing standard operating procedures and technical reports. Support multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus. Perform all duties in accordance with GMP requirements, SOPs and controlled documents recommendations relating to production management activities. Flexibility to take on additional tasks and responsibilities at the discretion of the Senior Manufacturing Director. Will act as a role model for the manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile The ideal candidate for this position, will have the following: Education: BSc in a scientific or engineering discipline is required. Masters level qualifications is advantageous. Knowledge/Experience More than 15 years experience in a cGMP biological manufacturing environment with previous experience managing and/or leading functional and project teams. Experience across both Upstream and Downstream manufacturing activities. Greenfield or large site expansion experience is beneficial. Experience working with lean principals and implementing CI processes within a complex manufacturing operation. Must have a proven track record of extensive manufacturing knowledge and experience gained within the biopharmaceutical/pharmaceutical industry sector. Significant expertise in manufacturing processes and systems. Proven track record in delivering large scale manufacturing projects. Technical Competencies Ideally, experienced in establishing a Manufacturing facility and large-scale design and construction project in a greenfield context of similar size and scale. Technology transfer to commercial facility and trouble shooting skills are important for this position. Demonstrated success in scientific and technical proficiency, bioprocess implementation, cGMP operation, and teamwork are critical for this position. Personal Skills: Excellent written and oral presentation skill, detail-oriented organizational skill, clear understanding of process control strategy and data management are also required for this position. Good decision making with strong judgment through collaboration and consideration of others point-of-view. Strong leadership competencies with demonstrated management skills Excellent people influencing and project management skills Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. Onerous requirements: Must be willing to travel as required internationally to fulfil the responsibilities of the position As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: Leadership MFG Bioprocessing Science Analytical Benefits: Bonus Parking Pension Sports & Social Club VHI

  • Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Senior Process Engineer MFG 7 Reporting to the Manufacturing Technology Lead, the Senior Process Engineer will play a pivotal role in establishing the Manufacturing Technology team, with responsibility for providing engineering support to the ongoing requirements for MFG 7 as well as supporting any future tech transfer projects into MFG 7. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU and Asia. We currently employ over 12,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies. Department Description As Senior Process Engineer MFG7 TechOps, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the MFG Technology Lead. Your Responsibilities Essential duties and responsibilities of this role include and are not limited to the following; Assist in site start up and project related activities: Support package owners on vendor management and equipment or process related activities and queries. Generate equipment verification & validation protocols and reports as required. Review vendor documentation for completeness and accuracy. Participate in FAT and vendor related activities. Support issue resolution during equipment installation, commissioning and qualification phases. Participate/Execute/Lead verification & validation related activities as required. Support CQV execution team as needed. Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state. Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit. Main point for communications with the Core Engineering group for MFG 7. Implement equipment CAPAs and performance improvements Execute and lead equipment verification, validation & revalidation protocols as required. Provide equipment technical support and troubleshooting. Provide routine Automation support, troubleshooting and maintenance. Champion and drive the implementation of Global Requirement Program tools and techniques within the Operation Unit. (for e.g. Operator Care, PdM, PMO, Work Management) Drive the use of PI to provide business efficiency Identify equipment improvement projects for Core Engineering Unit. Work with the portfolio management process to identify projects/support demands from the Core Units. Champion and Support Energy saving programs/projects within the Operating Unit. Write equipment assessments to support investigation closure. Conduct Investigation Trending. Change Control write up and close out. Lead / provide SME input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations including authoring investigation reports, technical assessments and summaries. Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented. Participate in cross-functional project teams as applicable. Provide input and work with the MFG leadership team to deliver the MFG objectives. Support audit preparation. Coach manufacturing team on OpEx tools and use OE systems as the basis for identifying improvements. Implement and support continuous improvements that reduce cycle times and operational costs. Coach production personnel in manufacturing equipment as required. Developing and maintaining a database for investigations, or other required department tracking and data analysis needs, as applicable. Complete biennial review and PQS updates. Support the disposition process. Ensure all data ready in timely fashion in support of Opu disposition metric. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Technology Lead. Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile: The ideal candidate for this position will have the following: Qualifications: Third level qualification in a Science or Engineering related subject is preferable. Knowledge/Experience: Minimum of 8 years experience in a large-scale in a Biopharmaceutical/pharmaceutical facility. Ideally, experienced in establishing a Manufacturing Technology team in a greenfield context of similar size and scale. Excellent communication skills including computer literacy and ability to work independently and in a team. Thorough knowledge of current Good Manufacturing Practices (cGMP). Experience and knowledge of DeltaV MCS platform preferred. Familiarity with Chromatography and Ultra filtration production operations is desired. Behavioural Competencies Strong leadership competencies with demonstrated management skills. Excellent communication skills including computer literacy and ability to work independently and in team. Strong leadership competencies with demonstrated management skills. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Self-starter and self-motivated; organized with good attention to detail. Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities. Results oriented, with the ability to manage multiple priorities in a short period of time. Collaborative and inclusive approach to work and colleagues. Engage cross functionally in conjunction with a site-based team. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. Other Requirements: Must be willing to travel as required internationally to fulfil the responsibilities of the position. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: Analytical Problem Solving MFG Process Development Engineering GMP Benefits: Bonus Life Assurance Parking Pension VHI

  • Training Coordinator  

    - Dundalk

    Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Training Co-ordinator (12 month fixed term contract) As Training Co-ordinator you will be reporting directly into the Training Lead. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia and Ireland. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As Training Co-ordinator, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. Your Responsibilities In this role, the responsibilities will include: Working closely with Training Specialists to support department training requirements. The Training Coordinator will be key to maintaining up to date training records and supporting the training team in general. Performs a key role in a very dynamic environment which will involves direct collaboration with functional areas in supporting the delivery of agreed training programmes. Tracks performance against training plans and provides reports regularly to support site and functional areas, with an objective to drive performance and compliance. Responds to calls, emails, audit requests and deals with general training queries, including the maintenance of the hard copy training files for staff and contractors. Liaises with functional areas to plan for upcoming training activities and collect and share trainee information. Organises training activities such as room bookings, catering, printing and administrative tasks such as ordering educational aids and materials, developes the Site Training Calendar. Gathers feedback from trainers and trainees after selected training. Liaise with external trainers/third party provider, consultants as required in the cordiantion of training Maintains the site training systems, with respect to data entry and reporting, the training coordinator is required to become an SME for these systems and work to ensure accurate data entry and ensure GDP requirements are met. Develops training reports and cascade this information to support site metrics. Supports a safe working environment by complying with all pertinent environmental health and safety practices, rules and regulations. Will act as a role model for the Training function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Provide OPEX support to departments across the site as required. Demonstrate the appropriate use of Lean techniques during OPEX projects. Influence, Coach/Train employees in Lean Techniques and Principles in order to develop an organization wide culture of change. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Will be flexible to take on additional tasks and responsibilities at the discretion of the Operations Director. Will act as a role model for the Operations function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile The ideal candidate for this position, will have the following: Education Third level education or equivalent professional experience in a similar role is essential. Knowledge/Experience Technical Competencies Experience using Learning Management Systems is required (i.e., MasterControl, Success Factors). Experience Experience as a training coordinator, with an understanding of training systems is a key requirement of the role. Experience managing training documentation and performing data entry is essential. Experience working in a GMP manufacturing environment is preferred. Personal skills Working in a team environment is an important feature of the role Strong interpersonal and communication skills are required Good experience managing mulitiple projects and a structured project management approach is advantageous Ability to collaborate and influence staff across all levels of the organisation is desirable Ability to work with minimal supervision Solutions focused and ability to drive continuous improvement Effective communication and written skill As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: Data entry Organisational Communication Benefits: VHI

  • Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 12,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Manufacturing Support Specialist The Manufacturing Support Specialist is a key member of the manufacturing team providing continuity across the 24/7 manufacturing shift teams. This role is responsible for providing day-based support to the Manufacturing teams to ensure that batch manufacture is running as intended. This role will focus on providing support to the shift teams to ensure that MFG reportable KPIs are consistently met. Main area for focus will be related to the following: GMP Documentation Right First Time Execution, review and close out Manufacturing Audit Readiness Training Compliance Continuous Improvement CAPA/Change control Safety OEE Organization Description As Manufacturing Support Specialist, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report into the Manufacturing Associate Director (Upstream/Downstream). Your Responsibilities In this role, you will be responsible for: Providing Cross Shift support to manufacturing personnel to promote best practice across 24/7 MFG shift teams. This role will be POC for the shift teams and be responsible for coordinating, screening and progressing improvement ideas generated from the Manufacturing Shift teams. This will be a varied and evolving role within the Manufacturing team which may also include leading manufacturing investigations, support continuous improvements and implementing good work practices for the shift teams Manufacturing Support Where appropriate provide MFG input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations. Support the disposition process, manage and track document execution and review. Participate in cross-functional project teams as applicable. Identify process improvement projects and implementation and work with MT and MSAT to priorities projects/support demands from the Business Unit. Coordinate communications across the shift teams to ensure consistent communication. Point of Contact for co-ordination of the Management of Cleaning Verification and Equipment Release. Compliance and Right First Time Execution Ensure manufacturing owned investigations & change controls are raised and closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented. Support audit readiness Internal facility audits and documentation tracking. Data gathering and trending where required to support process investigations. Support and lead a culture of Right-First Time (RFT) through partnerships with manufacturing shift teams and provide leadership in the use of Opex principles to optimize technical and business processes. Participates in HAZOPs and reviews documentation as required. Supports and monitors safety systems, safety audits and monitors behaviours and performance on shift as required and supports safety communications as required. Supports the investigation of safety or environmental incidents on shift as required and records, reports and resolves/escalates unsafe conditions or near misses that are observed. Perform all duties in accordance with GMP requirements, SOPs and controlled documents Will be flexible to take on additional tasks and responsibilities at the discretion of their manager Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture Your Profile Education: Third level qualification in a Science or Engineering related subject Knowledge/Experience: Familiarity with Biologics manufacturing processes (Bioreactors, Chromatography, Ultra filtration, etc.,) is required. Experience of investigations and change controls preferred. Understanding of OEE Minimum of 3-4 years experience in large-scale Biopharmaceutical Industry.? Thorough knowledge of current Good Manufacturing Practices (cGMP). Personal/Behavioural skills Interpersonal / Teamwork Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional matrix organisation essential. Excellent focus and attention to detail. Flexibility and positivity about change in a dynamic working environment Communication Skills Excellent communication skills (including computer literacy) with the ability to develop, build, present and defend investigations/root cause analysis in both written and verbal form. Project management Excellent organizational skills essential. Self-driven, able to handle multiple activities simultaneously, prioritizing as appropriate. Business acumen/commercial awareness Experience in continuous improvement using Lean manufacturing tools preferred. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: GMP GDP Organisiational Skills Project Management Data Analysis Benefits: Parking Pension VHI

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