Senior Process Engineer

1 day ago


Mount Holly Springs, Pennsylvania, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Process Engineer to join our Facilities and Engineering team. As a key member of our team, you will be responsible for designing, building, and qualifying new equipment and systems for drug substance production, as well as developing domain expertise to support operations upon start-up.

Key Responsibilities
  • Provide system ownership for Biopharmaceutical process equipment
  • Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems
  • Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order
  • Ensure systems are installed and operating safely and in sync with pertinent environmental health/safety practices, rules, and regulations
  • Commission and qualify systems in alignment with GMP requirements and interact with regulatory inspectors
  • System guidance to identify performance risks and implement risk reduction strategies
  • Provide problem-solving support to reduce production downtime, leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
  • Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
Requirements
  • Doctorate degree or equivalent experience
  • Strong knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems
  • Ability to analyze problems, develop, and propose engineering solutions in a scientific manner using data-driven techniques and analyses
  • Experience working in a regulated environment and familiarity with GMP quality systems/processes
  • Strong leadership, technical writing, and communication/presentation skills
  • Ability to work in a team-based environment and communicate effectively with cross-functional teams
What We Offer

As a Senior Process Engineer at Amgen, you will have the opportunity to work on cutting-edge projects, collaborate with a talented team, and contribute to the development of innovative medicines that improve patients' lives. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

Amgen is an Equal Opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive environment where everyone feels valued and respected.



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