GMP Project Manager (Pharma/Biotech)

Job Title: Project Manager

Location: Thousand Oaks CA

Looking for a Senior level PM who will support manufacturing plant and engineering group

• The Project Manager will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and client Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.).
• The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance. The position will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.
  
  Preferred Qualifications / Skills / Experience
  2+ years of relevant work experience with 1+ years experience in operations/manufacturing environment
  Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
  Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment
  Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution Experience with combination product / medical device quality systems verification
  Process equipment knowledge cell culture, fermentation, purification, filling, and packaging
  Process automation knowledge understanding of automation infrastructure, current technologies, and automation project execution / verification.
  Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
  

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