Associate Director, Aseptic Facility and Utility Design

Bristol Myers Squibb

. Review and approve global risk assessments and quality impact assessments related to contamination events and microbial control failures around Facilities & Utilities .

Posted 9/19/2026full-timeUnited StatesSenior💰 $161,950 - $215,867 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in aseptic processing, contamination control, and microbial risk assessment within regulated pharmaceutical environments, with a strong focus on quality oversight and regulatory compliance. Proven ability to lead cross-functional teams and drive quality by design initiatives across facility and equipment lifecycle management.

Highest-signal resume keywords

Aseptic Processing ExpertiseSterilization ValidationContamination Control Strategy DevelopmentRegulatory Inspection ExperienceLeadership in Quality Assurance

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Microbial Risk AssessmentEnvironmental MonitoringSterilization TechnologiesFMEAHACCPFault Tree AnalysisRisk Ranking and FilteringAseptic ManufacturingTechnical WritingQuality Standards Compliance

Soft Skills

LeadershipCollaborationCommunicationProblem-SolvingStrategic Thinking

Tools & Technologies

Cleanroom ClassificationAirflow Visualization TechniquesSingle-Use System QualificationCCS FrameworksIQ/OQ/PQ Qualification Programs

Industry Keywords

FDA Aseptic Processing GuidanceEU GMP Annex 1USPISO 13408PDA Technical ReportsPharmaceutical QualityBiologics ManufacturingRegulatory ComplianceQuality by DesignMicrobiology

Tech Stack

Tools & technologies

Airflow

About the role

Key responsibilities & impact

Review and approve global risk assessments and quality impact assessments related to contamination events and microbial control failures around Facilities & Utilities
Lead and author complex Business Technical Assessments for regulatory submissions, systemic issue resolution, and cross-site technical alignment
Develop investigation and inspection-readiness materials for systemic aseptic and microbial control issues
Serve as a subject matter expert on Facilities & Utilities during FDA, EMA, and other health-authority inspections
Serve as Global Quality SME for aseptic facility and utility design
Review and approve design packages, URSs, DQ protocols, and change controls for cleanrooms, barrier systems, and critical utilities
Define and maintain enterprise Quality standards for aseptic facility and utility design
Provide by-design oversight for facility, utility, and equipment changes to control microbial and particulate contamination risks
Serve as technical authority during capital projects, facility modifications, and technology transfers
Provide Quality oversight for WFI, Purified Water, clean steam, clean compressed gases, and HVAC/clean-air systems
Partner with Engineering and Validation on IQ/OQ/PQ qualification programs
Champion Quality by Design and risk-based thinking across facility and equipment lifecycle management
Oversee aseptic facility and utility design standards at ExM partners, including CMO/CDMO facility packages, CCS documentation, and utility qualification strategies
Support ExM facility and utility design risk assessments and drive remediation through quality governance
Own enterprise design standards for sterilization technologies, single-use technology, and consumable qualification
Define sterilization validation requirements and risk-based bioburden control strategies
Ensure sterilization design standards remain current with regulatory guidance and industry best practices
Partner across Quality, Operations, MS&T, Regulatory, and Supply Chain

Requirements

What you’ll need

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
10+ years of progressive experience in sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality
At least 4 years in a leadership or enterprise-level role
Deep technical expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment within a regulated pharmaceutical or biologics manufacturing environment
Experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA)
Proven experience designing or overhauling APS/media fill programs or CCS frameworks at a network or enterprise scale
Hands-on experience with sterilization validation and single-use system qualification
Expert-level knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1, USP, ISO 13408 series, and PDA Technical Reports TR22, TR13, TR70, and TR90
Strong command of contamination control strategy (CCS) development under EU GMP Annex 1
Proficiency in FMEA, HACCP, fault tree analysis, risk ranking and filtering
Familiarity with facility design standards, cleanroom classification, and airflow visualization techniques
Experience with EtO, gamma, steam (moist heat), dry heat, and VHP/HPV sterilization technologies
Requires up to 25% travel
Preferred: M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline

Benefits

Comp & perks

Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance
U.S.-based exempt employees: Flexible Time Off (FTO) without a set accrual limit, subject to manager approval
11 paid company holidays each year
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires, 11 paid company holidays, and 3 optional holidays
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, depending on eligibility
Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
Additional discretionary incentive cash and stock opportunities may be available