Scientist / Engineer (Visual Inspection), Sterile Drug Product Manufacturing, Science & Technology Full-time

Scientist/Engineer (Visual Inspection)

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. As part of a multi-functional team, you will ensure successful delivery of the project and oversee all technical aspects.

After project completion, you will support ongoing operations on site and act as a global SME within the company.

Key responsibilities include:

• Technical guidance for a new Vial (Liquid/Lyo) / Combi Visual Inspection and bulk packaging process area from Design to successful PPQ of products within the facility, and after which will support routine production within the facility.
• Ensure that start-up project scope and timelines meet the user requirements and work with the project & CQV team to facilitate delivery, validation and safe operation of the Visual Inspection equipment / processes.
• Acting Visual Inspection SME in support of internal and external audits and interface.
• Having in-depth knowledge of Visual Inspection process operations and equipment to support Manufacturing, Quality, Automation, Validation, and EHS for quality deviation investigation, change controls, and CAPA's.
• Technical SME for the Visual Inspection process & equipment, SDP's interface with Global AVI team and accountable for changes to ensure continued compliance of the manufacturing equipment. Develop and manage projects arising from changes and to improve equipment up times. Generation of scope and budget requirement for any Equipment/Automation improvements/modifications/projects.
• Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP's), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements.
• Support Technical Transfers and New Product Introduction. Part of a cross-functional project team, providing key Process/Equipment SME input during design stage and providing engineering support as required, during execution of NPI campaigns.

Qualifications and experience include:

• Strong technical knowledge of Sterile Drug Product manufacturing both from a process and equipment perspective. Specifically in the areas of Visual Inspection and associated equipment.
• Experience with design of visual inspection processes including, defect classification, particle control, Knapp execution and MVI qualification is desired.
• 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.
• The successful candidate must possess a Bachelor/master's in engineering, or Science related discipline. A minimum of 5 years' experience within Sterile Drug Product Manufacturing is essential.
• 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.

Why you should apply:

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You'll get a 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.

Uniquely interesting work, life-changing careers

With a single vision as inspiring as “Transforming patients' lives through science™ “, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.

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R1599865 : Scientist / Engineer (Visual Inspection), Sterile Drug Product Manufacturing, Science & Technology