Manager, Facilities & Engineering (Validation)

Penn Life Sciences; Langhorne (Bucks County); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental Insurance

Tuition reimbursement

Annual bonus eligibility

Paid Time Off and Flexible Holidays

Job summary

Penn Life Sciences in Langhorne, PA seeks an experienced Manager, Facilities & Engineering to lead integrated facilities, utilities, maintenance, commissioning, qualification, and validation efforts for sterile pharmaceutical manufacturing. The role ensures equipment, validated systems, and infrastructure remain compliant, reliable, and inspection-ready.

The ideal candidate will demonstrate strong leadership and technical expertise in pharmaceutical facilities, validation lifecycle management,

Qualifications

• Bachelor's degree in Engineering or a related technical discipline; advanced degree preferred.
• 8+ years of progressive experience in a cGMP-regulated pharmaceutical/manufacturing environment.
• Minimum 3 years of direct people-management or significant technical-leadership experience.
• Experience overseeing facilities, engineering, utilities, maintenance, commissioning, qualification, or validation activities.
• Experience in sterile, aseptic, injectable, or biologic manufacturing environments is strongly preferred.
• Strong knowledge of cGMPs, 21 CFR Parts 210 & 211, EU GMP Annex 1/15, and related guidance.

Responsibilities

• Lead and coordinate site facilities, engineering, utilities, maintenance, commissioning, qualification, and validation activities.
• Develop and execute the site Validation Master Plan, validation schedules, lifecycle requirements, and procedures.
• Direct commissioning, qualification, and validation activities for facilities, utilities, equipment, processes, cleaning, sterilization, and computerized systems.
• Oversee qualification and validation documentation (URS, risk assessments, IQ/OQ/PQ, protocols, reports, CAPAs, change controls).
• Provide technical oversight for utilities, manufacturing equipment, facility infrastructure, preventive maintenance, calibration, and reliability programs.
• Manage capital and expense projects, equipment installations, facility shutdowns, budgets, schedules, and deliverables.
• Lead and develop assigned technical personnel while coordinating with QA, Manufacturing, and other departments for inspections and readiness.

Skills

Leadership

Regulatory readiness

Project management

Quality and compliance

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Job Overview

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.

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.

Qualifications

• 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.

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

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.