Process Engineer 2

Merck•Indianapolis, IN

6d•Onsite

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, ensuring seamless integration into existing production lines and equipment. Manage multiple concurrent technical projects valued up to $250K, overseeing the full lifecycle from capital appropriation and budgeting to 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 (SME) 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 performing hydraulic, heat transfer, and material balance calculations. Author and update critical 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 optimize manufacturing equipment performance and process reliability.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering or other Life Science or Engineering discipline.
5+ years of work experience in pharmaceutical operations.
5+ years of work experience in US and European GMP requirements and FDA guidelines.

Nice To Haves

Master’s Degree in Chemical or Biochemical Engineering.
Strong Microsoft Suite, Microsoft Visio, and AutoCAD skills.
Experience with Kepner-Tregoe.
Experience with Root Cause Analysis methodology or FMEA.
Experience with Minitab or JMP.

Responsibilities

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, ensuring seamless integration into existing production lines and equipment.
Manage multiple concurrent technical projects valued up to $250K, overseeing the full lifecycle from capital appropriation and budgeting to 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 (SME) 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 performing hydraulic, heat transfer, and material balance calculations.
Author and update critical 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 optimize manufacturing equipment performance and process reliability.