Manager, Facilities & Engineering (Validation)

About the role

The Manager, Facilities & Engineering will lead the site's integrated facilities, engineering, utilities, maintenance, commissioning, qualification, and validation activities in support of sterile pharmaceutical manufacturing.

Responsibilities

• Lead and coordinate site facilities, engineering, utilities, maintenance, commissioning, qualification, and validation activities.
• Develop, maintain, and execute the site Validation Master Plan, validation schedules, lifecycle requirements, and supporting procedures.
• Direct commissioning, qualification, and validation activities for facilities, utilities, equipment, processes, cleaning procedures, sterilization systems, and computerized systems, as applicable.
• Oversee qualification and validation documentation, including URS, risk assessments, DQ, FAT, SAT, IQ, OQ, PQ, protocols, reports, deviations, CAPAs, and change controls.
• Provide technical oversight for critical utilities, manufacturing equipment, facility infrastructure, preventive maintenance, calibration, reliability, and equipment lifecycle programs.
• Manage capital and expense projects, equipment installations, facility shutdowns, contractors, consultants, budgets, schedules, and technical deliverables.
• Lead and develop assigned technical personnel while partnering with Quality Assurance, Manufacturing, Technical Services, and other departments to support inspections, qualification, and commercial readiness.

Requirements

• Bachelor’s degree in Engineering or a related technical or scientific discipline required; advanced degree preferred.
• Minimum 8 years of progressive experience in a cGMP-regulated pharmaceutical, biopharmaceutical, biotechnology, or similarly regulated manufacturing environment.
• Minimum 3 years of direct people-management, supervisory, or significant technical-leadership experience.
• Demonstrated experience overseeing pharmaceutical facilities, engineering, critical utilities, maintenance, commissioning and qualification, or validation activities.
• Experience supporting sterile, aseptic, injectable, biologic, or similarly controlled pharmaceutical manufacturing operations strongly preferred.
• Strong experience with Validation Master Plans, validation lifecycle management, critical utilities, capital projects, equipment reliability, and regulatory inspection readiness.
• Strong knowledge of cGMP requirements, 21 CFR Parts 210 and 211, EU GMP Annex 1, EU GMP Annex 15, and applicable engineering and validation guidance.

Qualifications

Commensurate with experience.

Skills

• Strong leadership and technical expertise in pharmaceutical facilities and engineering.
• Validation lifecycle management.
• Critical utilities.
• Capital projects.
• Equipment reliability.
• Regulatory readiness within a sterile manufacturing environment.

Benefits

401(k) with company match, Health, vision, and dental Insurance, Childcare expense reimbursement, Tuition reimbursement, Annual bonus eligibility, Annual merit increases, Paid Time Off and Flexible Holidays.

Pay

TBD

Schedule

TBD