Overview In this role, you will provide technical leadership and engineering support for small molecule API manufacturing, acting as front-line process engineer or supporting the process team. You'll preserve process knowledge, contribute to optimization, and help qualify equipment and systems as the site scales to GMP operations. You will collaborate across functions during startup and ongoing operations, applying data-driven methods to improve performance. This is a mission-driven role at a company focused on delivering life-changing medicines, offering a meaningful opportunity to shape scalable manufacturing.
Compensation / Benefits- 401(k) with company match
- pension
- medical, dental, vision, and prescription drug benefits
- flexible benefits (FSA/HSA)
- life insurance
- well-being benefits
Responsibilities- Serve as frontline process engineer or support frontline engineers on small molecule API manufacturing, including RCA, process documentation, and technical decisions on the shop floor
- Capture and maintain process knowledge artifacts (Operational Control Strategy, material/energy balances, kinetics, chemistry, equipment design basis) and analyze how equipment impacts process parameters
- Support equipment and process system qualification, contribute to User Requirements, Design Review docs, Verification test plans, and return-to-service activities
- Ensure correct application of Engineering Design Standards and Specifications in partnership with the Engineering Tech Center
- Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs
Key requirements- Bachelor's degree in Chemical, Biochemical, or Mechanical Engineering, or related STEM discipline
- Minimum of 3 years of experience in GMP manufacturing unit operations
- Proven ability to work independently and in cross-functional teams
- Experience with process data analysis, statistics, and process performance monitoring
- Willingness to adapt to startup and scale-up to full GMP manufacturing
- Cross-functional collaboration
- Coaching and mentoring technical staff
- Creative problem-solving and initiative
- GMP manufacturing operations
- Process optimization
- Process safety management (PSM)
