layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Associate Director, Aseptic Facility and Utility Design at Bristol Myers Squibb | LAYIQ

Risk Assessment & Quality Impact Governance
Review and approve global risk assessments and quality impact assessments (QIAs) associated with contamination events and microbial control failures around Facilities & Utilities.
Lead and author high-complexity Business Technical Assessments (BTAs) to support regulatory submissions, systemic issue resolution, and cross-site technical alignment when associated with Facilities & Utilities
Develop and maintain comprehensive investigation and inspection-readiness materials for systemic aseptic and microbial control issues, serving as a subject matter expert on BMS Facilities & Utilities during regulatory inspections (FDA, EMA, and other health authorities)
Aseptic & Microbial Control by Design
Serve as the Global Quality SME for aseptic facility and utility design, providing expert review and approval of design packages, User Requirement Specifications (URS), design qualification (DQ) protocols, and change controls associated with cleanrooms, barrier systems (RABS/isolators), and critical utilities.
Define and maintain enterprise-level Quality standards and requirements for aseptic facility and utility design, including cleanroom classification, airflow and pressure differential design, surface finish specifications, and drainability — ensuring alignment with EU GMP Annex 1 (2022), FDA Aseptic Processing Guidance, and ISO 14644 series.
Provide by-design oversight for facility, utility and equipment changes — both sterile and non-sterile — ensuring microbial and particulate contamination risks are systematically identified, assessed, and controlled at the design stage
Serve as the technical authority for aseptic design principles during capital projects, facility modifications, and technology transfers, integrating contamination control strategy (CCS) requirements into design specifications
Provide Quality oversight for critical utility systems — including Water for Injection (WFI), Purified Water (PW), clean steam, clean compressed gases, and HVAC/clean air systems — covering design, qualification, and ongoing microbial and chemical control requirements.
Partner with Engineering and Validation teams to ensure facility and utility qualification (IQ/OQ/PQ) programs adequately demonstrate microbiological and contamination control performance against defined acceptance criteria.
Champion Quality by Design (QbD) and risk-based thinking across all phases of facility and equipment lifecycle management
Provide oversight of aseptic facility and utility design standards at ExM partners (CMOs/CDMOs), reviewing facility design packages, CCS documentation, and utility qualification strategies as part of site qualification and ongoing oversight programs, as required.
Support quality risk assessments of ExM facility and utility design, identifying gaps relative to BMS standards and current regulatory expectations, and driving remediation through the ExM quality governance framework
Sterilization Standards & Single-Use Technology (SUT)
Own the development and governance of enterprise design standards for sterilization technologies, with expertise in single-use technology (SUT) and consumable qualification
Define sterilization validation requirements and risk-based bioburden control strategies for components, containers, and sterile fluid pathways, supporting both MS&T and Engineering in design decisions
Ensure sterilization design standards remain current with evolving regulatory guidance (e.g., ISO 11135, ISO 11137, ISO 11040) and industry best practices

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1606473 : Associate Director, Aseptic Facility and Utility Design

Associate Director, Aseptic Facility and Utility Design

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