Jimmy Dunehew
- Role
- Facilities Capex Engineer at MilliporeSigma
- Location
- Longmont, CO, US
- LinkedIn followers
- 500 followers
Experience
Facilities Capex Engineer
Mar 2022 — Present
Support second phase of 60MM design and build out of commercial Viral Vector Manufacturing facility including Process Development, QC Labs, Media, Buffer, Sterile Fill and Finish, and all GMP Impact / Non-Impact facility systems. Project includes DD, CD, URS, FRS development and review, start-up and management of all CQV aspects of a GMP facility.
Skills
- Biopharmaceuticals
- Sop
- Biotechnology
- Change Control
- Process Simulation
- 21 Cfr Part 11
- Instrumentation
- Lean Manufacturing
- Validation
- Computer System Validation
- Hvac
- V&V
- Root Cause Analysis
- Fda
- Manufacturing
- Quality System
- Aseptic Processing
- Capa
- Quality Assurance
- Lims
- Testing
- Gamp
- Corrective and Preventive Action (Capa)
- Cleaning Validation
- Process Engineering
- Gmp
- Automation
- Quality Control
- Commissioning
- Glp
- Calibration
- Technology Transfer
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