Process Engineer 2
About The Position
The Process Engineer 2 provides technical engineering oversight across commercial operations, including bulk formulation, fill-finish operations using RABS or isolators, and high-speed packaging. The role leads scale-up and technology transfer of clinical and commercial products and supports their integration into existing production lines and equipment. This position manages multiple technical projects, with values up to $250,000, across their full lifecycle—from capital appropriation and budgeting through execution and staffing. It serves as a primary technical contact for internal and external clients and coordinates deliverables across departments and contractors. The Process Engineer acts as a subject matter expert for process investigations, root-cause analysis, and continuous improvement. The role also designs and specifies bulk processing and filling equipment, performs engineering calculations, maintains site documentation for regulatory compliance, and develops or modifies control loops and PLC ladder logic to improve equipment performance and process reliability.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering, or another Life Science or Engineering discipline.
- At least 2 years of work experience in pharmaceutical operations.
- At least 2 years of work experience with US and European GMP requirements and FDA guidelines.
Nice To Haves
- Master’s degree in Chemical or Biochemical Engineering.
- Strong skills with Microsoft Suite, Microsoft Visio, and AutoCAD.
- Experience with Kepner-Tregoe.
- Experience with Root Cause Analysis methodology or FMEA.
- Experience with Minitab or JMP.
Responsibilities
- Provide technical engineering oversight for commercial operations, including bulk formulation, fill-finish (RABS/Isolator), and high-speed packaging.
- Lead scale-up and transfer of new clinical and commercial products and integrate them into existing production lines and equipment.
- Manage multiple concurrent technical projects valued up to $250,000, from capital appropriation and budgeting through execution and staffing.
- Serve as the primary technical point of contact for internal and external clients and coordinate deliverables across cross-functional departments and contractors.
- Lead process investigations as a subject matter expert, identify root causes for deviations, and implement continuous improvement initiatives.
- Design and specify bulk processing and filling equipment, including performing hydraulic, heat transfer, and material balance calculations.
- Author and update site documentation, including SOPs, P&IDs, electrical drawings, and validation protocols, to ensure regulatory compliance.
- Develop and modify control loops and PLC ladder logic to improve manufacturing equipment performance and process reliability.
Benefits
- Health insurance
- Paid time off (PTO)
- Retirement contributions
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
