Facilities & Validation Engineering Lead – Sterile Pharma

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

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,