3 Manufacturing jobs in Dundalk

Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: Manufacturing Support Specialist The Manufacturing Support Specialist is a key member of the manufacturing team providing continuity across the 24/7 manufacturing shift teams. This role is responsible for providing day-based support to the Manufacturing teams to ensure that batch manufacture is running as intended. This role will focus on providing support to the shift teams to ensure that MFG reportable KPIs are consistently met. Main area for focus will be related to the following: GMP Documentation Right First Time Execution, review and close out Manufacturing Audit Readiness Training Compliance Continuous Improvement CAPA/Change control Safety OEE Organization Description As Manufacturing Support Specialist, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report into the Manufacturing Associate Director (Upstream/Downstream). Your Responsibilities In this role, you will be responsible for: Providing Cross Shift support to manufacturing personnel to promote best practice across 24/7 MFG shift teams. This role will be POC for the shift teams and be responsible for coordinating, screening and progressing improvement ideas generated from the teams. This will be a varied and evolving role within the Manufacturing team which may also include leading manufacturing investigations, support continuous improvements and implementing good work practices for the shift teams Manufacturing support where appropriate provide MFG input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations. Support the disposition process, manage and track document execution and review. Participate in cross-functional project teams as applicable. Identify process improvement projects and implementation and work with MT and MSAT to priorities projects/support demands from the Business Unit. Coordinate communications across the shift teams to ensure consistent communication. Point of Contact for co-ordination of the Management of Cleaning Verification and Equipment Release. Compliance and Right First Time Execution,ensure manufacturing owned investigations & change controls are raised and closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented. Support audit readiness Internal facility audits and documentation tracking. Support and lead a culture of Right-First Time (RFT) through partnerships with manufacturing shift teams and provide leadership in the use of Opex principles to optimize technical and business processes. Participates in HAZOPs and reviews documentation as required. Supports and monitors safety systems, safety audits and monitors behaviours and performance on shift as required and supports safety communications as required. Supports the investigation of safety or environmental incidents on shift as required and records, reports and resolves/escalates unsafe conditions or near misses that are observed. Perform all duties in accordance with GMP requirements, SOPs and controlled documents Will be flexible to take on additional tasks and responsibilities at the discretion of their manager Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture Your Profile Education: Third level qualification in a Science or Engineering related subject Knowledge/Experience: Familiarity with Biologics manufacturing processes (Bioreactors, Chromatography, Ultra filtration, etc.,) is required. Experience of investigations and change controls preferred. Understanding of OEE Minimum of 3-4 years experience in large-scale Biopharmaceutical Industry? Thorough knowledge of current Good Manufacturing Practices (cGMP). Personal/Behavioural skills Interpersonal / Teamwork Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional matrix organisation essential. Excellent focus and attention to detail. Flexibility and positivity about change in a dynamic working environment. Excellent communication skills (including computer literacy) with the ability to develop, build, present and defend investigations/root cause analysis in both written and verbal form. Project management Excellent organizational skills essential. Self-driven, able to handle multiple activities simultaneously, prioritizing as appropriate. Business acumen/commercial awareness Experience in continuous improvement using Lean manufacturing tools preferred. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: Organisational BioProcessing Analytical MFG 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 company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As Manufacturing Systems Specialist, you will be responsible for establishing the Manufacturing Systems team within the Manufacturing Operations group. The incumbent will provide expert support to the manufacturing team in the areas of SAP, LIMS, finite scheduling (Orchestrate) and benchtop equipment. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We provide our clients with a world-leading open access technology platform and enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. Department Description As Manufacturing Systems Specialist, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will be reporting to the Manufacturing Systems Lead. Your Responsibilities In this role, you will be a key member of Manufacturing Operations team in WuXi Biologics Ireland. Provide expert support to the Manufacturing department in the areas of SAP, LIMS, Trackwise and Finite Scheduling. Process and System owner for Manufacturing benchtop equipment. Responsibilities in this area will include but are not limited to management of the MFG benchtop support e.g., vendors, maintain an accurate equipment list of benchtop equipment and ensure all required system SOPs are in place. Ensure all Manufacturing benchtop equipment are maintained in a qualified state by collaborating with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning). Co-ordinate vendor visits on site for bench top support, qualification and maintenance as needed. Provide input to budget for systems. Collaborate with MT and MSAT groups on technical transfer and process validation as required. Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections. Ensure that the MFG training team are supported regarding benchtop equipment training and troubleshooting as needed. Ensuring continual improvement of manufacturing documentation (SOPs MBRs, OJTs) for areas of responsibility to ensure they are current, accurate, and clear. Communicate operational status regularly to senior management, as required, at the appropriate level of detail. Assist the MFG systems lead to coordinate the work between theMFG systemsgroups and other functional groups to meet the production objectives and timelines. Responsible for identifying and assessing new models of benchtop and new equipment as required. Will be flexible to take on additional tasks and responsibilities at the discretion of theManufacturing Operations Associate Director and Systems lead. Support future initiatives such as electronic batch records, electronic logbooks, etc. on behalf of Manufacturing. Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile:The ideal candidate for this position, will have the following: Education Diploma, BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science Knowledge/Experience Required: More than 2 years in biopharmaceutical manufacturing. Experience with GMP systems such as SAP and Benchtop equipment qualification and operation etc. Ideally have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. Experience in working with the cross-functional teams. Strong team lead with the demonstrated ability to manage and support manufacturing operations in a flexible and dynamic team environment. A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant. The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification). Knowledge of GMP systems such as SAP and Benchtop equipment qualification and operation etc. Ideally knowledge and experience of scheduling software including Orchestrate. Personal skills Required: Ideally, experienced in establishing a Manufacturing department and working in a team in a greenfield context of similar size and scale. A strong collaborator with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports. Excellent verbal and written communication and presentation skills. Excellent people skills with the ability to work effectively with staff at all levels of the organisation. Ability to work on own initiative and be initiative-taking. Results oriented, with the ability to manage multiple priorities in a short period of time. Excellent organizational and planning skills and strong diligence As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! If you have the ability to thrive in a dynamic and fast-paced environment, dont miss out on this opportunity to join us. Apply now! Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: IT Networking Analytical Team Collaboration CGMP Benefits: Bonus Canteen Parking Pension VHI