The Biopharma cGMP Biopharma Senior Engineering/ Facilities Director is a proven leader within a dynamic cGMP work environment. Implement and Manage the Reliability Centered Maintenance program. Experienced with Biopharma MFG Facility Site engineering, facilities, RCM, manufacturing, utilities, commissioning, and validation. Strong Project Manager with ability to manage multiple projects and cross functional teams.

 

General Job Responsibilities include:

1. Establish/ Manage the Reliability Centered Maintenance (RCM) operations team to ensure uninterrupted MFG Facility Operations within compliance with appropriate regulatory and industry standards.

2. Implement and Manage the Reliability Centered Maintenance program.

3. Establish/ Maintain CMMS Equipment/ System PM/ Repair, Calibration, and HEPA Certification SOPs/ Process Flows.

4. Integrate RCM Job Plans for MFG Facility Site HVAC/ Utilities, Equipment/ Systems, and Facilities.

5. Lead in the execution of System Impact Assessments for the MFG Facility Site asset classification of direct/ indirect and manage Master Equipment/ System List.

6. Perform Failure Mode Event Analysis (FMEA) and Root Cause Analysis (RCA) on manufacturing equipment and revision of PM SOPs to reflect FMEA findings.

7. Establish facilities contracts to support painting, roof repair, welding, machine shop, electrical, office moves, pest control, security, EH&S, and janitorial.

8. Evaluate/ manage the MFG Facilities process equipment, facilities, utilities, and HVAC equipment spare parts requirements to ensure required like-for-like spare parts are on hand.

9. Defend the MFG Facility Site HVAC Cleanroom Systems, Utilities, Commissioning/ Validation Plans, and F&E Systems during inspections/ client audits.

10. Lead in the development of Biopharma MFG Facility Change Control development with change control documentation and support change efforts with technical team.

11. Manage the MFG Facility Site design, construction oversight, commissioning, validation, and MFG Operational readiness. 

12. Lead in the development/ management of Facility & Engineering MFG Operational Readiness requirements.

13. Manage Biopharma MFG Facility Site “As Built” drawings.

14. Lead in the development/ execution of the Commissioning and Validation Master Plans.

15. Lead the site the execution of the Validation activities (FAT, Commissioning, ACO, ICO, IOQ, and PQ).

16. Support the development of the capital engineering strategy to support the Engineering, Design, Build, CQV, and MFG Operational Readiness of MFG Facility Site.

17. Responsible for the management of the development, design, planning, execution, review and final sign-off of CQV protocols.

18. Manage the Capital Project Feasibility, Conceptual Design, BOD, Detailed Design, Construction Oversight, CQV, and MFG Operational Readiness Lifecycle Program.

19. Support the management/ approval of capital project strategy, project contracts, RFP procurement, budgets, bid assessments, project cashflows, and budget dashboards.

20. Leverage engineering standards, Quality by Design principles, experience which aligns with FDA, ICH, & ISPE guidelines.in supporting Detail Design of Biopharma MFG Facility site.

21. Identify project gaps and escalate remediation plans to the Governance team for approval.

22. Lead in the development of the Basis of Design, Request for Proposal, User Requirement Specifications, Design Specifications, Integrated Project Schedule, performance Dashboards, A3’s, Bid Assessments, and Risk Assessments.

23. Adhere to the Code of Federal Regulations (21CFR), Environmental Protection Agency (EPA), International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), and/or Federal, State, Local EHS regulations, and building codes.

24. Identify all lubricants, demonstrate control, and proper use of lubricants.

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EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Bachelor’s degree in engineering and/ or 15+ years of biopharmaceutical experience required.

• 10+ years of biopharma management, leadership, RCM, and engineering experience

• 5+ years pharmaceutical design, CQV, process equipment, utility, PM, calibration, capital project management, cGMP/ GLP environments and regulations experience required.

• Possess pharmaceutical engineering operational knowledge (Cleanroom design/ operations, process equipment, utilities, facilities, PM, Calibration, validation, & scheduling).

• Must possess strong ability to negotiate and influence others internally and externally.

• Ability to travel up to 25% (US and Internationally)

• Ability to work flexible work schedules.

• Excellent computer, verbal, and written communication skills

• Possess and demonstrate exceptional problem-solving skills.

• Proven ability to work in a lean organization and creatively tackle problems.

• Work independently in a matrix environment and manage multiple tasks simultaneously.