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Process Engineer
2 months ago
We are seeking a highly skilled Process Engineer to join our API Manufacturing team in Lebanon, IN. As a Process Engineer, you will play a critical role in the design, development, and implementation of processes and equipment for the production of Active Pharmaceutical Ingredients (APIs).
Key Responsibilities- Facility Start-up:
- Provide process engineering support to the Global Facility Delivery team to ensure right-first-time and on-schedule facility start-up.
- Define and own relevant aspects of the overall integrated Operational Readiness Plan.
- Own the Performance Qualification execution for area of responsibility.
- Develop and implement unit operation and equipment control strategy to sustain and optimize API processes.
- Support initial Operations Training requirements as the Equipment and Area SME.
- Lead/support the tech transfer of new processes into the facility.
- Facility Operations:
- Provide process engineering support in batch API supply or continuous platforms through application of chemical engineering fundamentals.
- Monitor, assess, and document equipment performance to maintain ongoing qualification.
- Develop and maintain the basis of safety for process equipment.
- Integrate mechanistic modeling, process simulation, and analysis into current and future processes to enhance process understanding and control.
- Identify and implement continuous improvement opportunities related to equipment and processes as a core member of the cross-functional process team.
- Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms.
- Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions.
- Bachelor's Degree in Chemical, Biochemical, Bioprocess, Process, or Mechanical Engineering.
- 5+ years of relevant experience in chemical or pharmaceutical manufacturing operations.
- Deep technical interest and understanding in the field of Chemical Engineering.
- Strong analytical and problem-solving skills.
- Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science, and engineering professionals.
- Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
- Guidance/mentoring of others through processes.
- Flexibility to meet business needs.
- Experience in PSM or GMP manufacturing facility.