Scientific Project Manager

1 week ago


Thousand Oaks, California, United States SSi People Full time
Job Summary

We are seeking a highly experienced Senior Project Manager to support our manufacturing plant and engineering group. The ideal candidate will have a strong background in process/utility engineering and quality assurance.

Key Responsibilities
  • Project Leadership: Lead project engineering and construction activities, ensuring alignment with engineering workstreams, including trades during construction, project management budget, schedules, safety, and Commissioning and Qualification Process (CQP).
  • Collaboration: Work in partnership with maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
  • Compliance: Collaborate closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) to ensure compliance with regulatory requirements.
  • Strategy Development: Support projects in defining strategies for quality systems verification and work with the process development/validation team to develop and document appropriate practices for characterization.
  • Preferred Qualifications
    • Bachelor's degree in engineering or another science-related field.
    • 2+ years of relevant work experience with 1+ year's 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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