Manager, Facilities & Engineering; Validation

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.

• 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, clean rooms, 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.

• 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.

• Bachelor’s degree in Engineering or a related technical or scientific…