Process Engineer  - CIP/ SIP/ Autoclave

Role: Process Engineer focusing on CIP, SIP, and autoclave systems within biopharmaceutical manufacturing at Amgen's new drug substance plant. Objectives include supporting GMP-compliant commissioning, qualification, startup, and ongoing operations of process equipment, ensuring safety, efficiency, and regulatory adherence. Responsibilities encompass lifecycle management of CIP/SIP/autoclave systems, troubleshooting, process technology transfer, and process improvement initiatives. Qualifications: Master’s degree or equivalent experience; 2+ years in biopharma manufacturing or engineering, with knowledge of GMP-controlled environment, bioprocess equipment (e.g., solution prep, chromatography, cell culture), and safety standards. Preferred: Bachelor’s in Chemical or Mechanical Engineering, prior experience with GMP bioprocess equipment, troubleshooting skills, and familiarity with capital projects and regulatory audits. High-value biopharma specifics include supporting biologics manufacturing, with emphasis on process systems critical to drug substance production, in a regulated, 24/7 environment. The role involves collaboration with corporate engineering, and may require domestic/international travel and flexible hours.