Process Engineer 2

Merck•Indianapolis, IN

11h

About The Position

Provide technical engineering oversight for all phases of commercial operations, including bulk formulation, fill-finish (RABS/Isolator), and high-speed packaging. Lead the scale-up and transfer of new clinical and commercial products, integrating them into existing production lines and equipment. Manage multiple concurrent technical projects valued up to $250K, from capital appropriation and budgeting through execution and staffing. Serve as the primary technical point of contact for internal and external clients, coordinating deliverables across cross-functional departments and contractors. Act as a Subject Matter Expert to lead process investigations, identify root causes for deviations, and implement continuous improvement initiatives. Design and specify equipment for bulk processing and filling systems, including hydraulic, heat transfer, and material balance calculations. Author and update site documentation, including SOPs, P&IDs, electrical drawings, and validation protocols, to support regulatory compliance. Develop and modify control loops and PLC ladder logic to improve manufacturing 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 into existing production lines and equipment.
Manage concurrent technical projects valued up to $250K, including capital appropriation, budgeting, execution, and staffing.
Serve as the primary technical contact for internal and external clients and coordinate deliverables across departments and contractors.
Lead process investigations, identify root causes for deviations, and implement continuous improvement initiatives as a Subject Matter Expert.
Design and specify bulk processing and filling equipment, performing hydraulic, heat transfer, and material balance calculations.
Author and update SOPs, P&IDs, electrical drawings, and validation protocols to ensure regulatory compliance.
Develop and modify control loops and PLC ladder logic to improve equipment performance and process reliability.