Senior Engineering Project Manager

4 days ago


Thousand Oaks, California, United States SSi People Full time
Job Title: Scientific Project Manager

We are seeking a highly skilled Scientific Project Manager to join our team at SSi People. As a key member of our engineering group, you will be responsible for leading project engineering and construction activities in alignment with our engineering workstreams.

Key Responsibilities:
  • Lead project engineering and construction activities in alignment with our engineering workstreams, including Trades during construction, project management budget, schedules, safety, and Commissioning and Qualification Process (CQP).
  • Support projects that are associated with cGMP equipment and facilities at Thousand Oaks (ATO), ensuring that new GMP equipment is installed and maintained in a validated state.
  • Collaborate with the maintenance, Project Management, Engineering Technical Lead, and manufacturing teams to develop and oversee the operation and reliability of equipment.
  • Work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance.
  • Support the development and documentation of appropriate practices for characterization, working with the process development/validation team.
Requirements:
  • Bachelor's degree in engineering or another science-related field.
  • 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.


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