Process Engineer
Trinity Consultants - Advent Engineeringa day ago
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OnsiteFull-timeMid
Summary
Trinity Consultants - Advent Engineering is seeking a Process Engineer to join their team in the San Francisco Bay Area. The role involves developing project scope, schedule, budget, and leading the implementation workstream in partnership with various teams.
About the Role
As a Process Engineer, you will be responsible for collaborating with maintenance, process development, project management, and manufacturing to ensure compliance with GMP and safety standards. Your tasks will include leading engineering improvements, developing project charters, conducting risk analysis, and ensuring validation protocols are executed in accordance with cGMP practices.
About You
Required:
- Bachelor's degree in engineering or other science-related field.
- 7 or more years of relevant work experience in operations/manufacturing environment.
- 5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated chemical manufacturing industry.
Preferred:
- Direct experience working within regulated environments (FDA, OSHA, EPA, etc.).
- Working knowledge and experience with cGMP procedures and engineering practices.
- Experience implementing risk-based verification on major GMP process equipment.
- Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging.
- Strong process automation knowledge and understanding of automation project execution.
Trinity Consultants - Advent Engineering
ADVENT provides a wide array of services supporting the entire phase of the product lifecycle - from conceptual design through production. Our innovative consulting services cover process development and qualification, process equipment design commissioning and qualification, and GMP facility design, automation, commissioning, and qualification.
San Francisco Bay Area