James Fisher
Engineering Director
- Role
- Senior Director - Environmental Sustainability at Amgen
- Location
- Lafayette, CO, US
- LinkedIn followers
- 500 followers
About James Fisher
BSChE, MSChE, MBA, P.E.• Manufacturing / industrial experience since 1989• Over 20 years personnel performance management experience; experience as first and second tier manager• Experience in design, commissioning, start-up, steady state operation, and retirement of equipment and processes• Strong understanding of many regulatory requirements and operating/manufacturing business systems• Hands-on equipment operation experience• Experience in unionized and non-union operating environments
Experience
Senior Director - Environmental Sustainability
Aug 2023 — Present · CO, US
Highlights:Leading team of sustainability engineers, scientists, and data scientists.Leading enterprise conservation initiatives, sustainability data management, climate related strategic initiatives, and external reporting.Fostering sustainability culture, ensuring enterprise-wide adoption of sustainability best practices and incorporation of sustainability into standard business processes/practices.Description:Provide leadership and advocate professional development of team tasked with the broad set of corporate sustainability topics including sustainability in capital projects, equipment performance monitoring and response, resource and waste data compilation, data assurance and dashboarding, and sustainability programs.
Education
Bucknell University
MS, Chemical Engineering
1995 — 2002
Lehigh University College of Business
MBA, Management
2002 — 2007
Lehigh University
Certificate of Pharmaceutical Regulatory Affairs
2007 — 2010
Bucknell University
BS, Chemical Engineering
1991 — 1995
Skills
- Capa
- Inspection
- Biopharmaceuticals
- Gmp
- Aseptic Processing
- Biotechnology
- Iso 13485
- Cleaning Validation
- Quality System
- V&V
- 21 Cfr Part 11
- Process Simulation
- U.s. Title 21 Cfr Part 11 Regulation
- Standard Operating Procedure (Sop)
- Validation
- Continuous Improvement
- Fermentation
- Management
- Training
- Quality Assurance
- Technology Transfer
- Process Control
- U.s. Food and Drug Administration (Fda)
- Project Management
- Software Documentation
- Root Cause Analysis
- Manufacturing
- Automation
- Pharmaceutical Industry
- Sop
- Fda
- Commissioning
- Engineering
- Troubleshooting
- Corrective and Preventive Action (Capa)
- Operational Excellence
- Change Control
- Purification
- Lean Manufacturing
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