Process Engineer

Job Title: Process Engineer III

Location: St. Louis, MO Area

Position Summary:

The Recombinant Mammalian Drug Substance (DS) Platform within the global MSAT organization is seeking a Process Engineer III to support commercial mammalian cell culture processes at Contract Manufacturing Organizations (CMOs). This position will play a vital role in providing technical oversight, supporting technology transfer, process validation, and lifecycle management of biologics drug substance manufacturing processes. The successful candidate will collaborate with cross-functional teams to ensure robust and compliant manufacturing operations across internal and external global sites.

Key Responsibilities:

Provide technical support for commercial biologics manufacturing processes at external CMOs.

Perform routine process monitoring and analysis for process consistency and improvement opportunities.

Serve as Person-in-Plant (PiP) to observe operations and communicate findings to internal teams.

Review manufacturing processes, deviations, and production data for assigned products.

Support and contribute to root cause investigations and deviation resolution activities.

Recommend process enhancements to improve product quality, recovery, and productivity.

Review and approve manufacturing documentation such as batch records, protocols, and control strategies.

Collaborate with internal and external stakeholders across Engineering, Manufacturing, and Quality functions.

Provide updates on manufacturing progress and assist in operational troubleshooting.

Preferred Qualifications:

Experience supporting GMP-compliant, commercial manufacturing environments

Hands-on experience in cell culture and/or downstream purification

Familiarity with equipment qualification and process validation activities

Experience with formal root cause analysis and risk assessment methodologies

Proficiency in data analysis and use of statistical tools/software

Demonstrated project leadership and cross-functional team communication

Strong technical writing and presentation skills

Proficient with Microsoft Word, Excel, and PowerPoint