Global Lead, Aseptic Facility & Utility Design

Bristol Myers Squibb; Dublin; On-site; EUR 120,000 - 180,000; Full time

Job summary

Bristol Myers Squibb in Ireland is seeking an Associate Director for Aseptic Facility and Utility Design to lead enterprise design standards for sterile manufacturing and critical utilities. You will drive risk-based design decisions, coordinate with Engineering, MS&T, Regulatory, and Supply Chain, and ensure alignment with EU GMP Annex 1 and ISO standards.

Travel up to 25% and a focus on quality governance, CCS, and sterilization technologies.

Qualifications

• BS in Microbiology or related scientific discipline required.
• 10+ years in sterility assurance, aseptic manufacturing or pharmaceutical quality with 4+ years in a leadership role.
• Experience authoring technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA).
• Proven track record designing or overhauling APS/media fill programs or CCS frameworks.
• Hands-on experience with sterilization validation and single-use system qualification.

Responsibilities

• Review and approve global risk assessments and QIAs for contamination events and microbial control failures.
• Lead and author high-complexity BTAs to support regulatory submissions and cross-site alignment.
• Develop and maintain investigation/inspection-readiness materials for aseptic and microbial issues.

Skills

Aseptic processing knowledge

Contamination control

Risk assessment methods

CCS development

Cross-functional collaboration

Education

B.S. in Microbiology or related scientific discipline

Job description

Bristol Myers Squibb in Ireland is seeking an Associate Director for Aseptic Facility and Utility Design to lead enterprise design standards for sterile manufacturing and critical utilities. You will drive risk-based design decisions, coordinate with Engineering, MS&T, Regulatory, and Supply Chain, and ensure alignment with EU GMP Annex 1 and ISO standards.

Travel up to 25% and a focus on quality governance, CCS, and sterilization technologies.