Manager, Facilities & Engineering (Validation)

Job Description

Job Description

About Penn Life Sciences
Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.

What You'll Do
The  Manager, Facilities & Engineering leads the site’s integrated  facilities, engineering, utilities, maintenance, commissioning, qualification, and validation activities in support of safe, compliant, and reliable sterile pharmaceutical manufacturing operations. This position provides hands-on technical and managerial leadership for critical facility infrastructure, clean utilities, manufacturing equipment, preventive maintenance, capital projects, equipment lifecycle management, and the site validation program. The Manager will play a critical role in advancing the facility from pre-commercial operations through regulatory inspection readiness, process qualification, and sustainable commercial manufacturing.

Key Responsibilities:

• Lead and coordinate site activities involving facilities, utilities, maintenance, engineering, commissioning and qualification, and validation.
• 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, manufacturing equipment, laboratory equipment, processes, cleaning procedures, sterilization systems, and computerized systems, as applicable.
• Oversee the preparation, review, execution, and closure of validation documentation, including User Requirements Specifications, risk assessments, Design Qualification, Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification, protocols, reports, deviations, and change controls.
• Support process validation, cleaning validation, sterilization validation, aseptic process simulations, and Process Performance Qualification activities in collaboration with Quality, Manufacturing, Technical Services, and other applicable functions.
• Oversee qualification and validation activities involving sterile manufacturing equipment and systems, including autoclaves, depyrogenation tunnels, filling equipment, lyophilizers, cleanrooms, HEPA systems, and temperature-controlled equipment.
• Provide technical leadership for facility infrastructure, manufacturing equipment, automation and controls, laboratory systems, and clean and plant utilities.
• Oversee the reliable and compliant operation of systems including Water for Injection, purified water, clean steam, process gases, compressed air, HVAC, electrical distribution, emergency power, chilled water, boilers, Building Management Systems, and Environmental Monitoring Systems.
• Establish and maintain effective preventive maintenance, corrective maintenance, calibration, reliability, spare-parts, and equipment lifecycle programs.
• Lead investigations involving equipment failures, utility excursions, qualification failures, atypical validation results, recurring maintenance issues, and other significant technical events.

What We’re Looking For

Experience:

• Minimum of 10 years of progressive experience within a cGMP-regulated pharmaceutical, biopharmaceutical, biotechnology, or similarly regulated manufacturing environment.
• Minimum of 3 years of direct people-management, supervisory, or significant technical-leadership experience.
• Demonstrated experience overseeing multiple technical areas involving facilities, engineering, utilities, maintenance, commissioning and qualification, or validation.
• Experience supporting sterile, aseptic, injectable, biologic, or similarly controlled pharmaceutical manufacturing operations strongly preferred.
• Demonstrated experience developing, executing, or maintaining Validation Master Plans and lifecycle validation programs.
• Experience supporting facility startup, equipment installation, technology transfer, Process Performance Qualification, pre-commercial readiness, or commercial manufacturing strongly preferred.
• Experience managing capital projects, engineering contractors, validation consultants, budgets, schedules, and technical deliverables.
• Experience supporting FDA inspections, pre-approval inspections, customer audits, or other regulatory assessments preferred.

Education:

• Bachelor’s degree in Engineering or a related technical or scientific discipline  required .
• Advanced degree in Engineering, Pharmaceutical Sciences, Business Administration, or a related discipline preferred.

Skills & Knowledge:

• Comprehensive knowledge of pharmaceutical facilities, critical utilities, engineering, maintenance, reliability, commissioning, qualification, and validation principles.
• Strong knowledge of 21 CFR Parts 210 and 211 and familiarity with 21 CFR Part 11, EU GMP Annex 1, EU GMP Annex 15, ICH Q9, ICH Q10, GAMP 5, and applicable ISPE guidance.
• Strong understanding of sterile manufacturing facilities, contamination-control principles, classified cleanrooms, HVAC systems, HEPA filtration, pressure cascades, and environmental controls.
• Strong technical knowledge of Water for Injection, purified water, clean steam, process gases, compressed air, electrical systems, boilers, chilled-water systems, emergency power, Building Management Systems, and Environmental Monitoring Systems.
• Strong knowledge of preventive maintenance, corrective maintenance, calibration, equipment reliability, asset criticality, spare-parts management, and equipment lifecycle planning.
• Ability to interpret engineering drawings, piping and instrumentation diagrams, equipment specifications, utility schematics, technical manuals, and vendor documentation.
• Project Management Professional, Professional Engineer, Certified Maintenance and Reliability Professional, ASQ, Six Sigma, GAMP 5, or related training or certification preferred but not required.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position, M-F during standard business hours
• Must be available to support planned shutdowns, equipment installations, validation activities, and urgent facility, utility, or equipment issues outside normal business hours when required.

Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.

Company Description

Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.