Principal Process Engineer

Role Summary

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

Responsibilities

• Coach and mentor front line process engineers in fundamental engineering activities for batch API supply or continuous platforms.
• Champion application of statistical thinking and data-driven decisions based on first principles to monitor process performance.
• Support and peer review root cause analysis for equipment and operational events and other technical documents.
• Identify process knowledge gaps affecting 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 equipment qualification and ensure suitability for intended purpose.
• Ensure changes, maintenance, and interventions do not adversely impact qualification state of equipment.
• Integrate mechanistic modelling, process simulation and analysis to enhance understanding and control.
• Identify and implement continuous improvement opportunities as a core member of cross-functional process team.
• Lead/support tech transfer of new processes and unit operations across batch and continuous 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.
• Provide guidance in development of test plans for Verification packages and critical components.
• Provide guidance on return-to-service requirements for equipment after interventions such as maintenance.

Qualifications

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

Skills

• Deep technical interest and understanding in Chemical Engineering
• Strong analytical and problem-solving skills
• Ability to work independently and within a diverse Process Team
• Ability to coach others and develop technical knowledge and skills
• Creativity to identify improvements and drive implementation
• Guidance/mentoring of others through processes
• Flexibility to meet business needs

Education

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline

Additional Requirements

• Role may begin remotely with occasional travel to Indianapolis HQ and new site area; relocation to the area will be required.
• Potential travel of less than 20% (domestic and/or international).