Manager, Facilities & Engineering (Validation)

Penn Life Sciences is seeking an experienced Manager, Facilities & Engineering to join our team in Langhorne, PA.

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. This role ensures that facility infrastructure, critical utilities, manufacturing equipment, and validated systems remain safe, compliant, reliable, and inspection-ready.

The ideal candidate will demonstrate strong leadership and technical expertise in pharmaceutical facilities and engineering, validation lifecycle management, critical utilities, capital projects, equipment reliability, and regulatory readiness within a sterile manufacturing environment.

This position’s responsibilities will include, but not be limited to the following:

• 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.

We are looking for applicants with:

• 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.

What we offer:

• 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

Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.