Jim Crotty

About Jim Crotty

Combined 30 years Personnel Leadership, Capital Project and Facilities Operations Management experience. Responsible for the Complete Project Cycle from Programming, Conceptual Design, Budgeting, Capital Approval, Bid Specification, Vendor Selection, Start-Up/Commissioning, Defining Maintenance Requirements, Final Product Hand Over, Commissioning, Validation and Training. Managed both full time and contract engineering personnel during Capital Projects and Plant Engineering/Maintenance functions and Regulatory Inspections involving all aspects of cGMP Facilities. Responsible for writing the Facilities and Utilities sections of the Site Master File and new BLA submissions.Primary SME to represent Facility and Utility Quality systems during GMP Regulatory Audits and Preapproval Inspections. Experience with (5) FDA GMP and (3) PAI,(5) EMA, Health Canada, Brazil (ANVISA),(4) Japan (PMDA), Korea, Mexico, and World Health Organization regulatory audits.

Experience

1. Head of Clean Utilities and Sustainability

   Sanofi

   Nov 2025 — Present · Framingham, MA, US

Education

• Massachusetts Maritime Academy

  Bachelor of Science, Facilities and Plant Engineering BSFE

  1995

• Massachusetts Maritime Academy

  Master of Science, Facilities Management MSFM

  1992 — 1998

Skills

• Autocad
• Capa
• Biotechnology
• Change Control
• Commissioning
• Process Engineering
• Validation
• U.s. Food and Drug Administration (Fda)
• Pharmaceutical Industry
• Gmp
• Manufacturing
• Project Engineering
• Quality System
• Engineering
• Continuous Improvement
• Corrective and Preventive Action (Capa)
• Six Sigma
• Fda
• Process Simulation
• Project Management
• Hvac
• Standard Operating Procedure (Sop)
• Instrumentation
• Preventive Maintenance
• Construction
• Facilities Management
• Maintenance Management
• Sop
• Quality Control
• Management
• Biopharmaceuticals
• Quality Assurance
• Cross-Functional Team Leadership