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, the US, the EU, and Asia. The company currently employs over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Job description: As Quality Specialist (QA for QC) you will be responsible for supporting the Pharmaceutical Quality System (PQS) in place, adhering to all regulatory, cGMP and company requirements. Organisation Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) 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, and Asia. 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 Quality Specialist (QA for QC) 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 to the QA for QC Senior Manager. Your Responsibilities Provide QA support for site start up, technical transfer and routine operations within QC department. Participate in the development, implementation and maintenance of the local Pharmaceutical Quality System (PQS). QA support for routine operations within QC department. Participate and lead as necessary, deviations, CAPAs, change controls, suspect analytical result investigations, laboratory and site investigations. Work with relevant departments to ensure timely closure of quality actions. Experience in generation, review and approval of quality documentation as required i.e. SOPs, CoAs, specification documents, protocols, reports etc. Assist in/Co-ordinate the preparation of reports such as the Annual Product Quality report. Play an active part in the continued development of the Pharmaceutical Quality System (PQS) by constructively challenging deficiencies and inefficiencies. Collaborating internally and also across the WuXi network to achieve quality goals. To actively support the development/implementation of continuous improvement activities and other quality activities may be assigned as required. Work with relevant department to ensure timely closure of quality actions. Collate and review data to be used in reports, investigations, key performance indicators (KPIs) and other quality metrics. Assist and participate in audits as required, including site regulatory audits and customer audits. 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 Senior Manager (QA for QC). Will act as a role model for the QA 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 Degree qualification in biopharmaceutical science or related discipline. Knowledge/Experience 5+ years experience in QA or QC. Experience in a GMP facility, preferably in the Biopharma/pharmaceutical industry. Familiarity with ICH, EU, and FDA GMP regulation Knowledge and proven experience in implementing investigational tools, root cause analysis and driving closure of investigations Behavioural Competencies Ability to conduct audits for QC area, to support our culture of compliance and to meet regulatory, market, EU, FDA, and Company standard. Strong leadership competencies with demonstrated management skills. Excellent interpersonal, verbal, and written communication 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 your colleagues. Excellent problem solving and troubleshooting skills. 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: QA QC Lab Investigations Deviations CAPAs GMP Benefits: Bonus Canteen Life Assurance Paid Holidays Parking 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 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: WuXi Business Systems Director Europe The WuXi Business Systems Director is responsible for promoting and facilitating the successful implementation of the Wuxi Business System at Wuxi Biologics Europe plants. They must be accountable for driving transformation through diligent use of WBS tools on Lean, Kaizen, innovation, and growth to influence the organization's culture with WBS mindset. The candidate should be hands-on and detail-oriented but also able to see the big picture. They need to think strategically and view the business from a site leaders standpoint. Also, they must be very customer-focused and have strong interpersonal and communication skills. The primary work will be in Ireland and Germany plants, and the position requires a minimum of 30% travel, with some support in EU, US or Asia as needed. Essential Duties and Responsibilities: Accelerate results in SQDIC by leveraging WBS tools, mentoring and consulting skills, and change management process. Lead the adoption and practices of the WBS Fundamentals throughout Europe plants in all functions. Lead with site/company leadership in developing a WBS roadmap to meet PD/KPI requirements and WBS Sustainability. Plan the cost-saving projects and sustain the kaizen results according to the top-down objectives. Provide formal and informal WBS training and coaching at Gemba. Conduct a productive kaizen funnel against the WBS KPI goals with a functional team and ensure the kaizen sustainment successfully. Ensure scorecard and KPI are effective and well-aligned with leadership and HR. Promote and facilitate diagnosis of workflow impediments and other wastes throughout the business, and provide expert counsel on appropriate tools to eliminate them. Promote and facilitate associate development in various WBS tools, lean production, and kaizen leadership. As Process Tool Owner for select WBS tools, promote the use and improvement of these tools and build a network of global CPs and ACPs to support Wuxi Biologics and BU needs. Benchmark and incorporate best practices. Experience: Demonstrated experience as an SME in a biopharmaceutical operation. Ability to promote synergy from cross functions and handle conflict. Ability to influence others at all levels in the organization (up and down). Must deliver sustainable results. Must possess the technical skills necessary to be credible by peers and managers. Effective communication in both written and verbal forms. Must understand how to leverage followership and leadership to drive sustainable change. Knowledge: 15+ years of manufacturing operations, engineering, quality, or supply chain experience. BS or BA Degree in Business or Engineering is required; a Masters Degree is preferred. Ability to design, develop, and implement a WBS roadmap for an operating business or site. Mastery of WBS Fundamentals and a variety of WBS Lean tools. Superior communication skills. Excellent English and preferrably Chinese skills (written and spoken). Superior training skills and adult learning theory. Familiarity with various manufacturing process technologies. Hands-on experience implementing WBS in a line management role. Proficiency in time and project management. Qualifications: High energy and able to handle conflict. Ability to operate in a fast-moving, ever-changing environment and effectively deal with difficult situations. A strong gemba-orientation. Quick study who can rapidly adapt to Wuxi Biologicss culture and gain the confidence of the organization. Behavioural Competencies: Adaptability working in a fast-paced environment and champion change. Results-driven and a proven record of being a high achiever. Ability to positively influence and work well with others. Self-motivated with excellent communication and interpersonal skills. Show leadership and support to junior team members. Strong analytical skills and comfortable making risk-based decisions. Skills: Operations Operations Excellence GMP Benefits: Bonus Canteen Parking 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 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 an OT Infrastructure Engineer, you will be a key member of the Global AIS team supporting WuXi Biologics Ireland. In this role, you will partner locally on AIS and OT technologies, managing and optimising OT infrastructure and applications to meet user, quality, and business requirements. You will support the design, integration, and lifecycle maintenance of OT network systems while ensuring compliance within a cGMP environment. This position is responsible for delivering reliable infrastructure services, driving continuous improvement, and supporting cross-functional teams to maintain robust and efficient manufacturing operations. Essential Duties and Responsibilities Infrastructure Role: Integral member of the Global AIS team at WuXi Biologics Ireland. As a local AIS and OT technology partner, Maintain/Manage OT infrastructure and applications; manage user requirements, annual budget planning and allocation, and inventory management. Work with suppliers to design, build and integrate OT network infrastructure, including networks, manufacturing domains, hyperconverged platforms (VMWare, Nutanix, etc.), backup systems, automated infrastructure support tools (e.g., SEPM, NTP, SMTP, File synchronization, RDS licensing, SIEM, Thin Manager, etc.), and various automation applications (OSI PI, SQL Server, Simatic Logon, PM Analyzer, Version Dog and Thin Manager, etc.). Report the progress of the work to the Management team. Build services for network infrastructure, including performance monitoring and alerting/backup and recovery/version control and Syslog, etc. Review and approve supplier documentation including design specifications, FAT/SAT and HSAT test specifications. Work with computer system validation and quality teams to ensure quality compliance in project implementation and operations. OT infrastructure lifecycle maintenance, patch management, network management and performance monitoring. Plan and install hotfixes, Windows, and other system updates. Planning, implementation and reporting of preventive maintenance, patches, and upgrades on manufacturing system networks. Continuous optimization of network infrastructure operations, including computer and account management, automated integration, service optimization, data collection and backup, security audits, etc. Draft, review and approve Change Requests, SOPs, Work Instructions and Design Specifications. Active participation in daily infrastructure tasks. Providing insights and recommendations that align with long-term objectives. Ensuring cross-functional collaboration and alignment with overall business strategy and goals. Flexibility to take on additional tasks and responsibilities at the discretion of the Global AIS and Local AIS Management. Will act as a role model for peers and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Cross-Functional Collaboration: Regular inter-departmental meetings to align tasks. Working closely with on site and above site senior leaders from manufacturing, quality, engineering and regulatory affairs to identify improvement areas and align efforts. Continuous Improvement Strategies: Developing and implementing continuous improvement strategies across Operational technology environment. Utilizing WBS, Lean and Six Sigma methodologies to enhance operational performance. Technical Expertise and Major Initiatives: Providing expert technical support to GMP Manufacturing / Laboratory Operations, engineering and warehouse areas. Technical Support for GMP Operations: Establishing robust technical support systems for GMP Operational Technology environment. Troubleshooting issues, implementing programme improvements, and ensuring systems remain validated and compliant at all times. Networking with manufacturing and quality organizations to maintain reliable process control for equipment and systems. Technical Competencies Experience with Dell multi-host blade systems, Microsoft Windows Server 2012, 2016 and 2019 experience. Virtualization operating experience (VMWare, Nutanix and Hyper-V). Experience with thin client software solutions. Understand standard documentation systems such as hardware design, network design, FAT and SAT. Experience with the Purdue model Understand cGMP, especially biopharmaceutical production and automation systems. Experience Degree in IT engineering, or other relevant Qualification or equivalent experience. Experience in a cGMP manufacturing environment or biologics process development. Experience working on projects and cross-functional initiatives Proven ability to work on own initiative in a prior role Ability to understand and communicate risks and develop and execute contingency plans Extensive experience in the operation of large-scale technology. Hands on experience with large scale technology operations. Knowledge In-depth understanding of large scale technology unit operations. Strong knowledge and experience in GMP environment and working within Quality System Strong knowledge and experience in project management. Behavioural Competencies Demonstrated ability to organize and support GMP technology systems. Strong Communication skills. A strong communicator with the ability to work well within a cross-functional team to achieve a common objective. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Be collaborative and inclusive in your approach to work and your colleagues. 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. WuXi Biologics is an equal opportunities employer. Skills: VMWare Nutanix and Hyper-V network design FAT and SAT 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 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, you will 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. 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: Protein Purification Media and Buffer Preparation Clean Utilities Benefits: Bonus 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, and EU. 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 Senior Cleaning Validation Engineer, you will support and lead the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at WuXi Biologics facility in Louth. The Cleaning Validation Engineer will validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. The position is accountable for timely completion of cleaning validation related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility. Essential Duties and Responsibilities Develop and implement cleaning strategies for Clean in Place (CIP) and Clean Out of Place (COP) systems. Ensure following EudraLex GMP guidelines. Lead cleaning validation projects for media, buffer, upstream and downstream equipment trains. Collaborate closely with colleagues within the Process Engineering and Validation team and cross functional departments (QA, Manufacturing, Automation and QC). Author and review cleaning risk assessments, technical protocols and reports and supporting documentation as required. Own the PEV procedures and plans associated with cleaning validation activities. Prioritise cleaning validation activities in line with the project schedule. Implement product change over assessments. Identify requirements for laboratory studies/trials to support cleaning validation activities and to consult closely with manufacturing/QC to oversee the design and execution of studies (as required). Identify and implement improvements where feasible to cleaning processes. Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale. Temporary shift working may be required during periods of engineering batch and validation batch execution. Provide on the floor support for troubleshooting cleaning related issues and lead manufacturing investigations into Cleaning Validation deviations. Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections. Will be flexible to take on additional tasks and responsibilities at the discretion of the Process Engineering and Cleaning Validation Lead. Will function as a role model for the Engineering function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Technical Competencies Experience of cleaning validation for drug substance and/or drug product processing equipment in a multiproduct facility. Experience in troubleshooting cleaning and cleaning validation challenges and providing solutions for GMP manufacturing. Experience A minimum of 8 years cleaning validation experience leading cleaning validation programmes in multiproduct facilities. Knowledge and experience with facility start-up projects (brown field or green field) is advantageous. Experience operating in a fully automated Delta V facility. Excellent communication skills including computer literacy and ability to work independently and in a team. Thorough knowledge of current Good Manufacturing Practices (cGMP). Familiarity with Chromatography and Ultra filtration production operations is desired. Qualifications BEng or BSc in Chemical / Process engineering or relevant science discipline is required. A postgraduate qualification in an engineering or scientific discipline would be advantageous. A qualification in project management would be advantageous. Behavioural Competencies Strong leadership competencies with demonstrated management skills. Good people skills coupled with demonstrated ability to collaborate effectively across functions and sites. Ability to present and successfully defend technical and scientific approaches in both written and verbal form. 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. Engage cross functionally in conjunction with a site-based team. 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! WuXi Biologics is an equal opportunities employer. Skills: Cleaning Validation cGMP Compliance CIP/COP Systems DeltaV Automation Chromatography Operations Technical Documentation Facility Start-Up Projects 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 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 Facilities Specialist you will be responsible for the safe and efficient operation and maintenance of the sites facilities systems in line with the relevant auditing (e.g. FDA/HPRA) and safety standards. The Facilities Specialist will own, control and manage the site facilities throughout the facility to deliver compliant systems capable of safe and continuous supplies to all points and users without interruption or impact. Ensure a contemporary design, a safe and compliant start-up and when in sustaining, an effective facilities operation, controls and monitoring system. Your Responsibilities In this role, you will act as SME for site facilities systems. Oversee the timely completion of system work orders and resolve issues if required, also ensuring compliance for same. Assist with continuous and reliable supply of facilities systems across the site. Oversee the planning and scheduling of system repair and maintenance activities. Support audits on the Facility and associate Compliance/Safety programmes. Point of contact for Facility related queries. Manage all Facilities contracts and contractors. Maintain review process for contracts e.g. Cleaning & Bundled Services, Integrated Security Systems, Catering, Kitchen Equipment, Site Security, Adverse Weather Services, Landscaping, Foul and Storm Drains, Pest Control, Roof Systems, Phones/Radios, Lifts, Gowning, ATEX Forklift, Cold Rooms etc. Liaise with Support / Maintenance contractors. Review and approve Facility system modifications, change requests, and SOPs. Conduct walk-downs / review of Facility installations and attend Factory/Site Acceptance Tests as required. Identify, build and implement Facility system training across the site, complete assigned training and identify gaps/opportunities for further training. Own and oversee the complete Facility system data build for the site. Develop and champion continuous improvement programmes that increase the performance and reliability of Facility equipment and systems. Develop mechanisms for monitoring, trending and reporting all Facility equipment and systems performance. Provide SME insight and technical leadership to the engineering, production and support areas. Conduct analysis of Bad Actors and drive a programme to improve reliability of equipment. Management and Control of associated site Facilities Operational Budgets, control and update procedures for all site Facilities. Ensure that all Maintenance Technicians are adequately trained in the test methods and procedures that they will be required to follow in the performance of their duties. Support Engineering Projects, Validation, Warehouse, QC/QA, Operations and other departments on all Facilities Projects/Issues. Project work with regard to specification, scope definition, budget preparation, detailed engineering design, purchasing, inspection, validation, installation and commissioning of all new facilities and buildings. Responsible for site insurance compliance, control and monitoring safe working practices. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPAs. Lead Deviation investigations within the department. Use lean six sigma tools to drive root cause analysis and CAPA completion. Ensure compliance with Safety, Quality, Environmental Regulatory and Corporate requirements. Support safety and environmental programmes. Adhere to safe working practices as set out in the Safety Statement and other company safety rules. 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 Facilities 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 Technical qualifications at third level or equivalent in Engineering and/or relevant experience in a Facilities role. Knowledge/Experience Minimum of 8 years engineering experience in a Facilities environment. Experience of sterile/biotech facilities within a pharmaceutical environment. Strong Safety mindset & awareness of the inherent system hazards demonstrated through an understanding of EHS & GMP compliance requirements (particularly from an Engineering perspective) & demonstrated capability within the Audit environment (specifically EHS). Demonstrated ability to work collaboratively with multiple customers to deliver shared goals. A proven track record of delivering continuous improvement and value across multiple process streams and customers. In-depth understanding of Facilities programmes, Helpdesk environment and supporting service/supplier contracts. Knowledge of safety standards, hazards and appropriate precautions applicable to maintenance work. Understanding of computerised maintenance management systems. Thorough knowledge of Safety, GMP and environmental regulatory requirements. Personal Skills Ability to lead & motivate multi-skilled facilities technicians. Ability to communicate with site management, production and quality personnel. Ability to produce technical reports on engineering/process issues. Strong leadership competencies with demonstrated management skills. Excellent interpersonal, verbal, and written communication skills. Able to think critically and demonstrate troubleshooting and problem-solving skills. Self-starter and self-motivated; organised 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 your colleagues. Excellent problem solving and troubleshooting skills. 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. WuXi Biologics is an equal opportunities employer. Skills: Facilities Management Maintenance Planning HVAC Systems Computerised Maintenance Management Systems Compliance Auditing Benefits: Bonus 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 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: Senior Manufacturing Systems Specialist The Senior Manufacturing Systems Specialist will play a key role in establishing the Manufacturing Systems team within the Manufacturing Operations group. The Senior Manufacturing Systems Specialist is a key technical resource responsible for supporting, maintaining, and optimising benchtop manufacturing equipment within a highly regulated production environment. This role emphasizes hands-on troubleshooting, operational support, and continuous improvement of manufacturing systems to ensure reliability, efficiency, and compliance with quality standards Department Description As Senior Manufacturing Systems 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 to the Manufacturing Systems Lead. Your Responsibilities Essential duties and responsibilities of this role include and are not limited to the following. Key member of Manufacturing Operations team in WuXi Biologics Ireland. Serve as the primary operational technical expert for benchtop manufacturing equipment, including installation, configuration, calibration, verification, and preventive maintenance. Mentor and train MFG Systems Specialists on best practices as required. Perform advanced troubleshooting of operational, functionality and integration issues to minimise equipment downtime and support daily production activities. Monitor equipment performance and operational data to identify trends, diagnose issues, and propose corrective or preventive actions to support operational readiness. Collaborate closely with manufacturing, quality, and engineering teams to support new equipment introduction, process changes, and system upgrades. Develop and maintain equipment documentation as required. Train the manufacturing operational team on the correct use and operational troubleshooting of benchtop systems. Ensure all equipment and processes meet applicable regulatory standards (e.g., GMP, ISO) and support internal and external audits. Coordinate with vendors and service providers for repairs, spare parts, and technical support. Participate in continuous improvement initiatives, focusing on equipment reliability, process efficiency, and reduction of recurring issues. Lead or support root cause investigations for equipment-related nonconformances using structured problem-solving methodologies. 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). 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: BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science Knowledge/Experience: More than 5 years in biopharmaceutical manufacturing. Ideally, experienced in establishing a Manufacturing department and building a team in a greenfield context of similar size and scale. Ideally, experienced in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. Experience with operating and troubleshooting of benchtop equipment is a distinct advantage. Experience with Commissioning, Qualification and Validation of benchtop equipment is a distinct advantage. Experience in working with the cross-functional teams. Experience with GMP systems such as MasterControl, Maximo and TrackWise etc. Strong team player 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. Knowledge of GMP systems such as MasterControl, Maixmo and TrackWise etc. Ideally knowledge and experience of scheduling software including Orchestrate Behavioural Competencies: A strong team player 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 interpersonal skills with the ability to work effectively with staff at all levels of the organisation. Ability to work on own initiative and be proactive. Results oriented, with the ability to manage multiple priorities in a short period of time. Excellent organisational and planning skills and strong attention to detail 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: MFG Benchtop Equipment GMP Networks Troubleshooting Benefits: Parking 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 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 Materials Team Lead 12mth Fixed Term Contract The Manufacturing Materials Team Lead will play a pivotal role in establishing the Manufacturing Materials Team within the Manufacturing Operations group. The incumbent will provide expert support to the manufacturing team in the areas of SAP, Abnormal Material Handling, Return of Materials to Warehouse, Stock Cycle Counts, Supplier Complaints and Material Replenishment activities. This role is being offered as a 12month Fixed Term Contract. Department Description As Manufacturing Materials Team Lead 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 to the Manufacturing Operations Lead. Your Responsibilities Essential duties and responsibilities of this role include and are not limited to: Key member of Manufacturing Operations team in WuXi Biologics Ireland. Provide expert support to the Manufacturing department in the areas of SAP, Abnormal Material Handling, Supplier Complaints, Stock Cycle Counts, Return of Materials to Warehouse and Material Replenishment activities. Business owner for SAP Production Planning. Responsibilities in this area will include but are not limited to management of the Manufacturing Materials Team performance. Ensure all required relevant SOPs are in place. Ensure all Manufacturing Material Storage Areas are maintained as per good housekeeping practices by collaborating with relevant departments on all aspects of 5S & Lean. Ensure the KPIs for MFG team are achieved in the areas of Manufacturing Materials Management. Preparation of budget input for areas of responsibility. Track and monitor budget spend on an annual basis. Collaborate with QA, Warehouse, Finance and SCM groups on Material Management activities as required. Collaborate with QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections. Ensure that the MFG Team are supported in regard to Material Management activities providing support 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. Key Manufacturing representative for non-SAP managed consumables including the goods receipt process as requested by Finance. Assist the MFG Operations Lead to coordinate the work between the Manufacturing Materials Team and other functional groups to meet the production objectives and timelines. 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 Operations Lead. Lead future initiatives such as 5S and continuous improvement projects for the areas in scope on behalf of Manufacturing. 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, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology, Pharmaceutical Science, Biopharmaceutical Science or Analytical Science. Knowledge/Experience: More than 5 years in biopharmaceutical manufacturing. Ideally, experienced in establishing a Manufacturing department and building a team in a greenfield context of similar size and scale. Ideally, experienced in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. Experience with electronic batch records a distinct advantage Experience in working with cross-functional teams. Experience with GMP systems such as SAP and TrackWise etc. 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. Knowledge of GMP systems such as SAP and TrackWise etc. Ideally knowledge and experience of scheduling software including Orchestrate. Personal skills: A strong leader 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 interpersonal skills with the ability to work effectively with staff at all levels of the organisation. Ability to work on own initiative and be proactive. Results oriented, with the ability to manage multiple priorities in a short period of time. Excellent organisational and planning skills and strong attention to detail 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 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 SAP Analytical GMP 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 Asial. 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 Materials Specialist The Manufacturing Materials Specialist plays a pivotal role in establishing the Manufacturing Materials team within the Manufacturing Operations group. The incumbent will provide expert support to the manufacturing team in the areas of SAP, Abnormal Material Handling, Return of Materials to Warehouse, Stock Cycle Counts, Supplier Complaints and Material Replenishment activities. 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. Department Description As Manufacturing Materials 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 report to the Manufacturing Materials Team Lead. Your Responsibilities Essential duties and responsibilities of this role include and are not limited to: Key member of Manufacturing Operations team in WuXi Biologics Ireland. Ensure following the requirements of EudraLex CGMP guidelines. Provide expert support to the Manufacturing department in the areas of SAP, Abnormal Material Handling, Supplier Complaints, Stock Cycle Counts, Return of Materials to Warehouse and Material Replenishment activities. Ensure all required relevant SOPs are in place. Ensure all Manufacturing Material Storage Areas are maintained as per good housekeeping practices by collaborating with relevant departments on all aspects of 5S & Lean. Ensure the KPIs for MFG team are achieved in the areas of Manufacturing Materials Management. Collaborate with QA, Warehouse, Finance and SCM groups on Material Management activities as required. Collaborate with QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections. Ensure that the MFG Team are supported in regard to Material Management activities providing support 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 Operations Lead to coordinate the work between the MFG Materials Team and other functional groups to meet the production objectives and timelines. 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 Operations Lead. Execute future initiatives such as 5S and continuous improvement projects for the areas in scope on behalf of Manufacturing. 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, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology, Pharmaceutical Science, Biopharmaceutical Science or Analytical Science. Knowledge/Experience: More than 2 years in biopharmaceutical manufacturing. Ideally, experienced in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. Experience in working with the cross-functional teams. Experience with/Knowledge of GMP systems such as SAP and TrackWise etc. A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant. Ideally knowledge and experience of scheduling software including Orchestrate. Personal skills: Excellent verbal and written communication and presentation skills. Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation. Ability to work on own initiative and be proactive. Results oriented, with the ability to manage multiple priorities in a short period of time. Excellent organisational and planning skills and strong attention to detail 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: SAP Organisational Skills Attention to Detail Benefits: 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 12,000 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. 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 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: MFG Systems Biologic Processing Troubleshooting Benefits: Bonus Parking Pension VHI
