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Senior manufacturing systems specialist

Dundalk
WuXi Biologics
Systems specialist
Posted: 3h ago
Offer description

Senior Manufacturing Systems SpecialistThe 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 standardsOrganization DescriptionWuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re 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 DescriptionAs Senior Manufacturing Systems Specialist, you'll 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 ResponsibilitiesEssential 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 ScienceKnowledge/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 OrchestrateBehavioural 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 detailOther 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 potentialIf 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 - don't miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply nowWuXi Biologics is an equal opportunities employer.Would you like to know more before you apply? Please visit us at or contact us via

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