Associate Director, Aseptic Facility & Critical Utilities

Bristol-Myers Squibb Company; Seattle (WA); On-site; USD 178,000 - 216,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Wellbeing support and comprehensive &

Job summary

Bristol Myers Squibb seeks an Associate Director, Aseptic Facility and Utility Design, to lead aseptic design across facilities and utilities. You will own risk assessments, participate in regulatory submissions, and drive CCS strategies with cross-functional teams in a global context.

The role emphasizes leadership in sterile processing, design validation, and ongoing microbiological control, with a focus on compliance with FDA/EMA guidance and ISO standards.

Qualifications

• 10+ years in sterility assurance, aseptic manufacturing, or pharmaceutical quality.
• 4+ years in a leadership or enterprise-level role.
• Experience authoring and defending positions for regulatory inspections.
• Proven track record designing or overhauling CCS frameworks at enterprise scale.

Responsibilities

• Lead risk assessments and quality governance for facilities & utilities.
• Author and lead high-complexity BTAs for regulatory submissions.
• Develop investigation and inspection-readiness materials for aseptic issues.
• Act as technical authority for aseptic design during capital projects.
• Oversee design standards for sterilization technologies and CCS.

Skills

Aseptic processing

Contamination control

Risk assessment

Regulatory inspections

Cross-functional partnership

Quality by design (QbD)

Change controls

Education

B.S. in Microbiology

MS in Microbiology or related

Job description

Bristol Myers Squibb seeks an Associate Director, Aseptic Facility and Utility Design, to lead aseptic design across facilities and utilities. You will own risk assessments, participate in regulatory submissions, and drive CCS strategies with cross-functional teams in a global context.

The role emphasizes leadership in sterile processing, design validation, and ongoing microbiological control, with a focus on compliance with FDA/EMA guidance and ISO standards.