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 the Principal Wastewater Utility Engineer you will be primarily responsible for managing the sites wastewater systems including process, foul, and storm water as well as supporting the implementation and ongoing performance of a new major wastewater pretreatment plant. This includes overseeing contractor/vendor management, system performance, regulatory compliance, and safety. The role also involves design oversight, safety reviews, scope definition, operational expenditure (OPEX) budget management, and project/change management. A key focus will be on driving safety, operational excellence, and continuous improvement within the Utilities Engineering team. As a senior member of the Utilities team, the individual will ensure that all wastewater systems meet applicable regulatory, environmental, and company standards. The role includes mentoring junior engineers and supporting the sites GMP operations and environmental licensing requirements. Essential Duties and Responsibilities Act as a key Utilities Engineering representative for WuXi Biologics Ireland. Lead and manage all activities related to the site's wastewater systems and pretreatment plant. Collaborate closely with internal teams and external vendors/contractors to meet departmental goals. Ensure the proper design, commissioning, maintenance, and operation of new and existing utility systems. Maintain high standards in safety, GMP, and environmental compliance. Plan and manage utilities engineering support for manufacturing and plant shutdowns. Lead the preparation for regulatory audits and agency inspections. Drive continuous improvements to maximise equipment uptime and efficiency. Act as the subject matter expert (SME) for the wastewater pretreatment system from design through to operation. Develop and monitor KPIs, vendor performance, and service level agreements (SLAs). Support the sites sustainability and ISO 50001 energy management goals. Maintain complete and accurate documentation in the sites maintenance and calibration systems. Support engineering capital projects and ensure timely and cost-effective delivery. Promote and exemplify the WuXi Biologics PROUD culture and core values. Technical Competencies Strong background in utilities engineering within a regulated manufacturing environment. Experience in managing complex vendor contracts and utility service agreements. Strong knowledge of EHS, environmental licensing, energy efficiency, and wastewater systems. Experience 8+ years in engineering roles with emphasis on wastewater systems and EPA compliance. Proven leadership in cross-functional teams and project delivery ideally within the pharmaceutical or biologics industry or other applicable industries. Experience in strategic planning, budgeting, and performance reporting. International or multi-site experience is advantageous. Knowledge Demonstrates an in-depth understanding and experience in the application of Engineering principles, concepts, practice, and standards in the EU and internationally. Significant expertise in relevant Utilities Engineering systems and processes. Significant expertise in contractor/vendor control and management, including but not limited to set up and management of contracts (MSA/SLA). Knowledge of safety, GMP, sustainability and environmental regulatory requirements. Qualifications Technical qualifications at third level or equivalent in an Engineering related discipline. Masters level qualification advantageous. Behavioural Competencies Effective leadership and communication skills. Strong organisational skills and ability to manage competing priorities. Collaborative team player with a positive and flexible mindset. Ethical, proactive, and self-motivated. Committed to continuous improvement and mentoring others. Skills: Wastewater Treatment Systems GMP Compliance Environmental Licensing 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 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As the Principal Mechanical Utility Engineer, you will be responsible for the safe, efficient operation and maintenance of all mechanical utility systems on site, ensuring full compliance with relevant regulatory, environmental, and safety standards. This role entails full ownership of utility systems to deliver reliable, uninterrupted services to all users and processes across the facility. The successful candidate will foster a culture of operational excellence, continuous improvement, and safety within the Utilities Engineering team. As a senior leader, they will mentor engineers, support GMP operations, and ensure environmental licensing and sustainability targets are achieved. Essential Duties and Responsibilities Serve as a senior representative for Utilities Engineering at WuXi Biologics Ireland. Lead and manage all activities related to mechanical utility systems, including Plant steam, chilled water and compressed air. Ensure systems are designed, commissioned, operated, and maintained to the highest standards. Act as the Subject Matter Expert (SME) on all mechanical utility systems, ensuring compliance with regulatory and GMP requirements. Collaborate with internal teams and external contractors/vendors to support departmental goals and system reliability. Drive preventative and predictive maintenance strategies to maximise uptime and energy efficiency. Lead preparations for regulatory inspections and internal/external audits. Develop and monitor key performance indicators (KPIs), service level agreements (SLAs), and contractor performance. Provide utilities engineering support during manufacturing campaigns, shutdowns, and capital projects. Promote and support a strong EHS, sustainability, and ISO 50001 energy management culture. Maintain accurate, up-to-date documentation within the sites maintenance and calibration systems. Contribute to strategic planning, budgeting, and performance reporting for engineering operations. Promote and exemplify the WuXi Biologics PROUD culture and core values. Technical Competencies Extensive experience in mechanical utilities engineering within a regulated manufacturing environment. Strong knowledge of GMP compliance, EHS, environmental licensing, energy efficiency, and wastewater systems. Skilled in managing complex contractor relationships and utility service agreements. Familiarity with ISO standards, particularly ISO 50001. Experience 8+ years in engineering roles with emphasis on wastewater systems and EPA compliance. Proven leadership in cross-functional teams and project delivery ideally within the pharmaceutical or biologics industry or other applicable industries. Experience in strategic planning, budgeting, and performance reporting. International or multi-site experience is advantageous. Knowledge Demonstrates an in-depth understanding and experience in the application of Engineering principles, concepts, practice, and standards in the EU and internationally. Significant expertise in relevant Utilities Engineering systems and processes. Significant expertise in contractor/vendor control and management, including but not limited to set up and management of contracts (MSA/SLA). Knowledge of safety, GMP, sustainability and environmental regulatory requirements. Qualifications Bachelors degree (Level 8 NFQ or equivalent) in Mechanical Engineering or a related discipline. A masters degree and/or professional certification (e.g. Chartered Engineer, PMP, Energy Manager) is advantageous. Behavioural Competencies Demonstrates strong leadership and effective communication. Highly organised, with the ability to manage competing priorities. Collaborative and adaptable with a positive, proactive mindset. Committed to mentoring and developing team members. Ethical, self-driven, and capable of influencing across departments. Enthusiastic about continuous improvement and sustainable practices. Skills: Wastewater Systems GMP Compliance Project Management Budget Management Utilities Engineering Contractor Management Sustainability Benefits: Bonus Educational assistance 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 provides services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Employee Relations Lead This role leads employee relationship (ER) for Ireland, UK and some other EU countries. This role will proactively offer advice and solutions to HR teams as well as country business leaders regarding the full spectrum of HR topics from employment law perspective, including, but not limited to, recruitment, compensation and benefits, retention, discrimination, harassment, performance, discipline and separations. This role will also provide support on routine operational employee data related matters per companys policy and SOPs. 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. 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 Employee Relations Lead, 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 Senior HR Director. Your Responsibilities: Advise, mentor and guide internal stakeholders around complex HR decisions, including performance management, retention, discrimination, harassment and separations. Lead performance, disciplinary, grievance, investigations, and conflict resolution cases in line with policy and legislation. Collaborate with HRBP and business leaders to manage complex leaves of absence, sickness absence and sensitive negotiations. Partner with Business Partners, Centres of Excellence (COEs), SSC teams to review HR policies from employment law perspective. Design and deliver employment law trainings to coach internal stakeholders. Act as the first line of defence per the companys privacy data policies and SOPs, and collaborate with Compliance team on GDPR related projects and complex business scenarios not yet detailed defined. Lead business change projects, including M&A, people integration, restructuring and reorganizations. Identify evolving and unique challenges and proactively provide risk mitigation solutions. Monitor legislation developments and trends and provide proactive solutions. Manages or participates in HR projects as needed. Your Profile The ideal candidate for this position will have the following: Qualifications: Bachelors degree or above in Human Resources, Business Administration or related majors A post-graduate certificate or diploma in employment law Knowledge/Experience: Minimum 8+ years of relevant employee relations experience, focused on ER investigations, employment legal, performance management, compliance, and/or other applicable HR experiences Knowledge of employment law; EMEA knowledge of local legislation specifically UK & Ireland. Solid knowledge of all aspects of employment laws in the licensed country. Experience in advising on employee data collection, process and protection. Experience with issues such as harassment, discrimination, ethical issues, etc. Behavioural Competencies Hands-on, solution-oriented, and ability to provide actionable solutions. Strategic thinker. Knowledgeable of market best practices. Ability to recognize trends and identify systemic approaches to solving problems. Excellent interpersonal skills to communicate with teams of all levels with different cultures and education background. Proficient multi-tasking with strong attention to details. Team oriented person with excellent follow-up skills. Passion for learning, self-motivated, energetic and enthusiastic. 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: Emloyment Law Employee Relations Negotiations 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 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 Bioprocess Shift Lead MFG 6.2 US you will be responsible for supporting all operational readiness activities to ensure the facility design meets end user requirements. Upon successful commencement of commercial operations, the role will evolve to leading a team of highly trained professionals in the manufacture of biological products in adherence to the highest standards of quality and regulatory compliance. The Shift lead will be responsible for the recruitment, development, and retention of the team to consistently deliver on the specific KPIs and to meet with the expectations of our customers. 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 Israel. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description AsBioprocess Shift 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 be reporting to theManufacturing Associate Director. Your Responsibilities In this role, youwill be aKey member of Manufacturing leadership team for WuXi Biologics Ireland. Will playan important rolein theexecution of the business plans, ensuring cross functional collaboration and leadership execution. Responsible for the Bioprocess Associates assigned to the shift on an ongoing basis. Senior Person on Site during Shift Hours (Weekends and Evenings) with some responsibility over shift personnel in Maintenance and support functions during this time. Supervision on a day-to-day basis, training and communications, assignment and prioritization of work, delivery of objectives, performance management including development of direct reports, resolution and escalation of grievances and disciplinary issues. Responsible for emergency procedures, safety systems, safety performance, communication, and behaviours on the shift. Performs safety audits and walk downs as required. Participates in HAZOPs and reviews safety documentation as required. Liaises with statutory agencies when required. Reports and leads the investigation of safety or environmental incidents on the shift and records, reports and resolves/escalates unsafe conditions or near misses that are observed. Acts as Area Owner for the Permit to Work system in manufacturing during normal day shifts and in all areas across site in the out of hours. Ensures that the plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements as required. Provide technical support to the MFG Shift team as required. Provide instruction, training, and guidance to the Shift team during MFG operations. Execute production activities where required to support training and development of personnel. Reports and investigates batch deviations or quality issues on the shift and escalate issues promptly. Raises change controls and emergency change controls where required. Oversees the review of completed documentation and is responsible for RFT on shift. Conducts any checks, inspections, or audits necessary. Responsible for housekeeping and audit preparations in assigned areas. Ensures that relevant risk assessments are completed. Manage training for their shift team and own the respective training plan. Assist in maintaining a safety orientated Culture, cGMP compliant work environment always. Where necessary assist in Facility and Equipment starts up and Validation activities. Manages day to day operations on shift. Ensures functional area targets, objectives and performance criteria are understood and met. Aligns shift activities with changing business needs. Prioritizes tasks and assigns resources accordingly. Makes informed technical decisions where appropriate and escalates issues promptly. Works cross-functionally and cross-shifts to resolve issues and drive improvements. Responsible for schedule adherence metric on shift; drives performance to ensure throughput and changeover targets are met. Supports technical transfer activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products. Write, review, revise and approve of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions Seek opportunities for Continuous Improvementusing Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc.) Always maintain the designated place of work in a clean and tidy state during production activities. 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 Manufacturing Associate Director. Will act as a role model for the manufacturing functionand 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 degree in science, chemical engineering, or a related field is preferred but not essential. Knowledge/Experience Minimum of 8 years supervisory/leadership experience in the pharmaceutical/biopharma industry in a direct manufacturing support role. Extensive experience in leading teams, supporting the continued development of employees, motivating, and engaging them to achieve their potential. Expert experience in dealing with, resolving employee grievances, and always maintaining a positive and progressive work environment/culture. In-depth knowledge of relevant cGMP, safety, and environmental regulations. Expert knowledge and experience of the manufacturing equipment and associated processes. Excellent knowledge of the documentation standards and protocols in a pharmaceutical/biopharma manufacturing environment. Personal skills Strong leadership 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 organizational 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 ator contact us via WuXi Biologics is an equal opportunities employer. Skills: GMP Management Leadership GDP Benefits: Bonus Educational assistance 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: About the Role: As a Senior HR Business Partner, you will serve as a trusted advisor to business leaders and employees across a defined business area. You will drive HR strategy, lead key people initiatives, and ensure compliance with German labor law while fostering a constructive and transparent relationship with the works council (Betriebsrat). Your role will be pivotal in shaping a people-centric, legally sound HR environment that supports both business goals and employee engagement. Key Responsibilities: Act as a strategic partner to business leaders on all HR-related topics, including workforce planning, talent development, performance management, and organizational changes Provide expert guidance on German labor law and ensure HR practices comply with legal and regulatory requirements Manage a full spectrum of employee relations matters (e.g. disciplinary actions, contract changes, dismissals), in coordination with legal and compliance teams Build and maintain a constructive and cooperative relationship with the works council, including participation in negotiations, hearings, and consultations under the Works Constitution Act (BetrVG) Support and lead change management and restructuring processes within the business unit Design and implement HR policies and initiatives that align with both local regulations and global HR standards Drive the implementation of HR processes and tools, including performance reviews, compensation cycles, and talent programs Analyze HR data and KPIs to inform strategic decision-making and improve HR service delivery Coach and support leaders on people management, team dynamics, and leadership development Ensure smooth coordination with HR centers of expertise (recruiting, compensation & benefits, learning & development, etc.) Your Profile: University degree in Human Resources, Business Administration, Law, Psychology, or a related field At least 5 years of professional experience as an HR Business Partner or in a similar generalist HR role, ideally in a matrix or international environment In-depth knowledge of German labor law and proven experience in working with a works council (Betriebsrat) Strong communication and stakeholder management skills, with the ability to influence and build trust at all levels of the organization Strategic mindset combined with hands-on execution capability High level of discretion and professionalism in handling confidential matters Fluent in German (C1+) and English (B2+) both written and spoken Proficient in MS Office; experience with HRIS systems (e.g. Workday, SAP SuccessFactors) is a plus Skills: HR Employment Law Works Council Performance Reviews
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 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! Would you like to know more before you apply? Please visit us at 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 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 Lead Drug Substance (DS) Manufacturing- Associate Director A critical role within the QA organisation, the QA Drug Substance (DS) Manufacture Lead will lead the QA team. Responsible for ensuring that biologic drug substance manufacturing is performed in compliance to cGMP, site SOPs and controlled documents from end-to-end, covering warehouse and supply chain management operations, manufacturing operations, batch certification by QP, batch release and shipment for biologics drug substance manufactured in WuXi Biologics Ireland. 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. Department Description As QA DS Manufacture Lead, 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 Director of Quality, WuXi Biologics. Your Responsibilities In this role, you will: Lead the QA teams responsible for 24/7 oversight of Warehouse and Supply Chain Management (SCM), Drug Substance Manufacturing Operations and the QA team responsible for batch disposition operations. Develop, implement, and monitor the quality systems relating to warehouse, SCM and manufacturing and batch disposition operations. Provide QA review and approval of SOPs, master batch records, quality risk assessments, change controls and other documentation, as applicable, associated with Manufacturing, Warehouse, SCM and batch disposition operations. Review and approve deviation reports, CAPAs, and technical documents to support GMP decisions and batch disposition. Ensure online QA presence in Warehouse and Manufacturing areas during operation, as required. Lead the GMP Release program. Liaise with internal and external teams, as appropriate, to ensure that all deviations, investigations, and batch record review comments are adequately addressed and closed out in a timely manner as defined in SOPs. Liaise with internal and external teams, as appropriate, to ensure that all CAPAs, change controls, internal audit observations are addressed and closed out in the required time frame. Ensure timely and efficient disposition of biologics drug substance batches. Supervise direct reports on a day-to-day basis, provide training and communications, assignment, and prioritisation of work. Manage performance, delivery of objectives and career development of direct reports. Ensure clear communication on issues and timely escalation as applicable. Support inspection/audit readiness activities, act as SME for QA DS function during regulatory inspections and Client audits, prepare responses to observations, monitor implementation of follow-up actions. Lead and/or represent QA on multidisciplinary teams including New Product Introduction (NPI), Technology Transfer and continual improvement projects. Perform internal and external audits, as required. Identify and drive opportunities for continuous improvement. Champion site metrics and KPIs to ensure targets are achieved, met and counter measures in place when applicable. 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 Director of Quality. Will act as a role model for the QA function and also the wider organisation in adherence to the WuXi Biologics corporate core values and PROUD culture. Your Profile The ideal candidate for this position, will have the following: Education: A Bachelors degree in a technical discipline (e.g., biochemistry, chemistry, engineering) would be an advantage. Knowledge/Experience Required: 8 plus years experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or similar. Candidates from Warehouse, Distribution (GDP) or Manufacturing Operations disciplines within the biotechnology and/or pharmaceutical industry will be considered but knowledge of Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required to be demonstrated. Experience managing a QA operations team would be an advantage. Experience in performing internal audits would be an advantage. Experience interacting the regulatory Inspectors would be an advantage. Experience working in a CMO in Client-facing role would be an advantage. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Personal skills Strong technical aptitude (i.e., able to read & comprehend technical documentation & execute procedures). Strong knowledge of cGxP requirements and regulations. Knowledge of trouble shooting and problem-solving skills, e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc. Demonstrated knowledge of Quality Management System and continuous/process improvement tools. Adaptable, able to multi-task and handle tasks with competing priorities effectively. Strong sense of urgency with a drive to close actions to closure on time and in full. Excellent interpersonal and communication skills. Excellent organisational skills. Proactive attitude. Excellent attention to detail. Other Requirements There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. Must be willing to travel when required. There will be a requirement for direct reports to work shift pattern once the project phase is complete. Delegation of Responsibilities When absent from the site, duties and responsibilities (with exception of QP confirmation/ certification of biologics drug substance) will be delegated to the following designates: Job Title: Senior Director of Quality Job Title: QA Drug Substance Group Leader, QA for WH Group Lead 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: Problem Solving Analytical skills Attention to Detail Leadership Management Benefits: Bonus Educational assistance Life Assurance 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: 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. 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 ator contact us via WuXi Biologics is an equal opportunities employer. Skills: Problem Solving Analytical BioProcessing Upstream and Downstream 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 benefits 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: Legal Counsel The Legal Counsel will report to the Director, Corporate Counsel for Europe who is based in Ireland and provide advice on legal and compliance issues for our business in Ireland. 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. 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 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As Legal Counsel, 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 Director Corporate Counsel, Head of Legal Europe. Key responsibilities will include: Developing an in-depth understanding of WuXis CRDMO business model and shared corporate support services. Supporting the Director, Corporate Counsel for Europe and wider European and Global legal team to provide all required legal services to the Irish business and sites. Drafting, negotiating and advising on a wide range of contracts, including but not limited to, commercial contracts, procurement of goods and services. Establishing and maintaining relationships with various internal stakeholders including Procurement, HR, Finance, Manufacturing, Quality, Engineering, Business Development, IT and Supply Chain. Supporting various cross functional and multi-regional projects with a leading role in Ireland. Instructing and working closely with external counsel in the region. Supporting legal work in other areas such including Litigation matters. Analyse business-related laws and regulations and any changes that may impact the business Draft, review and approve policies, procedures, bylaws, resolutions and other documents related to local operation and regulatory compliance. Will act as a role model for the function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Qualifications Required: Qualified lawyer with relevant PQE Experience Required: Knowledge of the pharmaceutical industry (inhouse or within a legal firm) an advantage as would experience in another manufacturing industry. At least 5+ years of related work experience in life science industry or law firm. Fluent in English in both written and oral. Technical Competencies Required: Ability to analyse complex legal issues, Strong verbal & written communication skills with high ability to influence and negotiate. Understand the need to know and structure communication accordingly. Behavioural Competencies: High level of accuracy of work and ability to operate without supervision. A team player with a collaborative way of working and ability to deal with a varied workload. Proven ability to work effectively with tight time pressures & demanding clients. 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: Legal Litigation Analytical Global Teams Communication English 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 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As the Associate Director, Process Equipment & Validation, you will oversee the lifecycle of process equipment and validation at the Dundalk site, including project delivery, qualification/validation, ongoing requalification/revalidation, and system retirement. As a key member of the Engineering Leadership Team, you will ensure activities meet GMP, GDP, data integrity (ALCOA+), corporate standards, and global regulatory requirements. The role is accountable for customer delivery, audit readiness, and compliance excellence while building a high-performing team to support WuXi Biologics Irelands strategic and operational goals. This senior leadership role reports to the Senior Engineering Director. Responsibilities Serve on the Engineering Leadership Team, contributing to site strategy, operational planning, and cross-functional decision-making. Define and execute the Process Equipment & Validation strategy, aligned with corporate and global engineering standards. Provide leadership to embed a compliance-first, customer-focused, delivery-driven culture and integrate engineering deliverables into commercial manufacturing operations. Own the lifecycle of process equipment and validation activities from project initiation to commissioning, qualification, requalification, revalidation, and retirement. Ensure technical and compliance governance for validated systems including process equipment, cleanrooms, utilities, laboratory systems, cleaning validation, thermal mapping, and computerised systems. Lead design, specification, procurement, commissioning, qualification, and validation of GMP laboratory, utilities, computerised, manufacturing systems, and cleanroom environments for capital projects and new products. Partner with Operations, Quality, and Project Management to deliver projects on time, within budget, and compliant with cGMP, corporate, and regulatory requirements (ISPE, ASME BPE, EHS). Lead investigations into deviations, non-conformances, validation issues, and process equipment failures, implementing science-based, risk-focused CAPAs. Maintain inspection readiness for process equipment and validation systems and act as SME for audits and regulatory inspections (HPRA, EMA, FDA, client audits), ensuring documentation, systems, and practices are audit-ready. Uphold standards of Good Documentation Practice (GDP) and ALCOA+ compliance. Provide technical support to Operations (QC, Utilities, Warehouse, Cell Culture, Purification) to ensure compliant operations. Drive continuous improvement initiatives to enhance process reliability, reduce revalidation burden, improve efficiency, and support technical innovation. Collaborate with Quality, Manufacturing, and Global Engineering teams for consistent delivery and customer satisfaction. Lead, mentor, and develop a high-performing Process Engineering and Validation team, promoting accountability, technical excellence, and continuous learning. Act as a role model for WuXi Biologics values and PROUD culture, ensuring staff engagement, development, and recognition. Person Specification Proven experience establishing, developing, and scaling Process Engineering/Validation functions in greenfield or large-scale biotech environments. Expertise in process equipment and validation lifecycle management within a cGMP-regulated biotech/biologics environment. Knowledge of biotechnology manufacturing operations, large-scale unit operations, validation standards, and global regulatory requirements (HPRA, EMA, FDA). Proven ability to lead project delivery, validation strategy, and audit/inspection management. Familiarity with ASME BPE, ISPE, EHS standards, and Quality Systems. Experience & Qualifications Degree in Life Sciences, Chemical/Biological Engineering, or related discipline. 10+ years in cGMP manufacturing or biologics process development, with significant leadership experience. Track record of leading cross-functional teams, capital projects, regulatory inspections, and delivering complex technical programmes. Experience delivering projects while ensuring compliance, cost-effectiveness, and business continuity. Hands-on experience with large-scale biotech unit operations and bioprocess development. Knowledge In-depth understanding of biochemical engineering principles, process data analysis, and GMP systems. Familiarity with global standards including ASME BPE, ISPE, and EHS frameworks. Leadership & Behavioural Competencies Strategic thinker with effective communication, stakeholder engagement, and strong execution skills. Collaborative, inclusive, and adaptable leader who drives performance and innovation. Ethical, proactive, and committed to continuous improvement and team development. Inspires and develops high-performing teams through coaching and mentoring. Strong communicator and influencer, able to build trust across functions and with senior leadership. Acts with integrity, accountability, and a customer-first mindset. Champions continuous improvement and compliance excellence. Additional Requirements Support international sites and global engineering initiatives, including audits, as needed. Perform other duties as assigned by the Engineering Director. In the Associate Directors absence, delegate responsibilities to an equivalent-level lead within the department, as appropriate. WuXi Biologics is an equal opportunites employer. Skills: Process Equipment Design Validation Lifecycle Management GMP Compliance cGMP Manufacturing Bioprocess Engineering ASME BPE Project Management Benefits: Bonus Life Assurance Pension VHI
