California Licensed Process Engineer

Job Summary

Leading process systems engineering activities for biologics manufacturing, the full-time California Licensed Process Engineer will ensure compliance with regulatory standards while managing engineering initiatives, validation efforts, and project management in a remote work environment.

Key responsibilities:

• Lead and manage engineering activities for advanced biotechnological systems, including utilities and process equipment
• Direct validation initiatives to ensure compliance with cGMP, FDA, and EMA regulations
• Oversee cross-functional engineering projects from conception through completion, balancing timelines and budget constraints

Required qualifications:

• Bachelor's or Master's degree in Engineering or Biotechnology with a minimum of 10+ years of relevant experience
• Proven leadership experience in managing teams and large-scale Capex projects
• Extensive knowledge of biopharmaceutical manufacturing processes and equipment
• Expert-level knowledge of cGMP, FDA, EMA, and ICH guidelines
• Strong understanding of bioprocessing, including upstream and downstream processing