BMS Cruiserath Biologics is hiring a permanent Scientist/Engineer (Visual Inspection) for its new Sterile Drug Product Manufacturing Facility. Reporting to the Associate Director, you will serve as the Technical SME for the Visual Inspection process and related equipment.
Requirements
- Strong technical knowledge of Sterile Drug Product manufacturing both from a process and equipment perspective.
- Experience with design of visual inspection processes including, defect classification, particle control, Knapp execution and MVI qualification.
- Knowledgeable on current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area.
- Familiar with start-up of new Sterile Drug Product manufacturing facility from initial design through to the final qualification of the equipment and process.
- First-hand experience of qualification and validation of Sterile Drug Product manufacturing equipment and/or processes. Specifically in Visual Inspection /CCIT and associated equipment.
- Understanding and experience of the principles of Annex 1/ USP 1790 / USP 790 and how they translate into visual inspection strategy for vial and syringe operations.
- Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture
- Experience with Qualification and Validation of new equipment is essential, as well as experience interacting with regulatory agencies.
- Experience with ANSI sampling plans and inspection data trending is desirable.
- Previous experience with a biologics startup in a large-scale drug substance facility and a good understanding of systems such as MES & SAP is desired.
- The candidate will have demonstrated proficiency in communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills.
- Problem solving and project management ability, as well as lean manufacturing experience is essential.
Benefits
- Competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.
