Principal Process Engineer

Role Summary

Principal Process Engineer responsible for technical leadership and expertise in production operations, including coaching and mentoring front line process engineers, developing and sustaining process knowledge, process and equipment support, process optimization, equipment qualification, and asset management. Supports production operations in small molecule or peptides manufacturing.

Responsibilities

• Coach and mentor front line process engineers in all aspects of fundamental engineering activities for batch API supply or continuous platforms.
• Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles.
• Support and peer review root cause analysis for equipment and operational events and other technical documents.
• Identify process knowledge gaps that impact equipment and process capability.
• Develop or support the capture of key process knowledge (material and energy balances, kinetics, chemistry, equipment design basis, etc).
• Support, develop and maintain the basis of safety for process equipment.
• Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs).
• Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose.
• Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the equipment.
• Integrate mechanistic modelling, 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 core member of cross-functional process team.
• Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms.
• Provide technical oversight of ongoing equipment qualification requirements.
• Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose.
• Provide guidance in development of test plans for Verification packages and associated critical components.
• Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance.

Qualifications

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline
• 5+ years of experience in API Manufacturing Unit Operations

Skills

• 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.
• Ability to coach others for development of technical knowledge and skills.
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.

Education

• None beyond the qualifications listed above

Additional Requirements

• Travel up to less than 20% may be domestic and/or international.
• Role may begin remotely with occasional business travel to Indianapolis and relocation to the area of the new site.