Senior/Principal Process Engineer

Role Summary

Senior/Principal Process Engineer responsible for supporting ATMP manufacturing at a greenfield facility in Lebanon, IN. Focus on process engineering for batch and continuous API production, facility start-up, qualification, tech transfer, and ongoing operations to enable GMP manufacturing readiness.

Responsibilities

• Facility Start-up: Provide Process Engineering support to the Global Facility Delivery team with a focus on right first time and on-schedule facility start-up (design reviews, process safety assessments, User Requirements, C&Q support, unit operation shakedown and startup, facility operational readiness).
• Define and own aspects of the integrated Operational Readiness Plan (SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, PQ requirements/protocol development).
• 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 modelling, process simulation and analysis into current and future processes to enhance understanding and control.
• Identify and implement continuous improvement opportunities related to equipment and processes as a core member of a 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 corrective and preventative actions.

Qualifications

• Bachelor's Degree in Chemical, Biochemical, Pharmaceutical, Biomedical, or Mechanical Engineering
• 3+ years of relevant experience in manufacturing operations (prefer chemical, pharmaceutical)

Additional Skills

• Deep technical interest and understanding in Chemical Engineering.
• Experience in ATMP manufacturing.
• Strong analytical and problem solving skills.
• Ability to work on own initiative and as part of a diverse Process Team.
• Creativity to identify improvement opportunities and drive implementation.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.