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´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. We have sites/offices in China, the US, the EU and Asia.
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.
- 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 (SOP’s MBR’s, OJT’s) 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 the MFG systems groups 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 the Manufacturing 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.
- Diploma, BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science
- 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.
- 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 - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now!