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Senior Manufacturing Engineer

2 months ago

Thousand Oaks, California, United States EPITEC Full time
Job Summary

We are seeking a highly skilled Senior Manufacturing Engineer to join our team at EPITEC. As a key member of our engineering team, you will be responsible for supporting manufacturing activities associated with cGMP equipment and facilities in Thousand Oaks.

Key Responsibilities
  • Develop and oversee the operation and reliability of equipment while driving safety and quality compliance.
  • Support the department and capital projects, providing data to support business cases and long-term strategy.
  • Provide direct engineering technical support, including risk-based verification on major GMP process equipment/automation projects.
  • Collaborate with cross-functional teams to identify critical quality parameters and process attributes for new equipment or facility modifications.
  • Develop and maintain business metric performance, ensuring alignment with company goals.
Requirements
  • Doctorate degree or Master's degree with 3 years of engineering and/or manufacturing experience, or Bachelor's degree with 5 years of experience.
  • 7+ years of relevant work experience, with 5+ years in operations/manufacturing environments.
  • Direct experience with regulated environments (FDA, OSHA, EPA, etc.) and cGMP procedures.
  • Strong process equipment knowledge, including cell culture, fermentation, purification, filling, and packaging.
  • Strong process automation knowledge, including automation infrastructure, current technologies, and automation project execution/verification.
Preferred Qualifications
  • Bachelor's degree in engineering or another science-related field.
  • Experience implementing risk-based verification on major GMP process equipment/automation projects.
  • Understanding and awareness of industry/regulatory trends for verification/validation.
  • Experience with combination product/medical device quality systems verification.