Senior MES Consultant (Biopharmaceutical / Bioprocess Manufacturing)
About The Position
The Senior MES Consultant will drive delivery of an MES project within a GMP-regulated bioprocess manufacturing environment, combining MES expertise with hands-on bioprocess knowledge to deliver a compliant, robust solution. The consultant serves as the senior MES lead and primary point of contact for client stakeholders, translating bioprocess manufacturing workflows into MES solutions and overseeing MBR/EBR design, configuration, and integration with ERP, automation, and other site systems. The role also coordinates the project team, timelines, risks, and progress reporting while ensuring compliance with applicable GMP and data integrity requirements.
Requirements
- Degree in engineering, life sciences, computer science, or a related discipline.
- 10+ years’ experience in life sciences manufacturing systems, including lead-level MES delivery.
- Strong background in biopharmaceutical / bioprocess manufacturing.
- Hands-on experience with a leading MES platform, such as PAS-X, Syncade, PharmaSuite, or Opcenter.
- Sound knowledge of GMP, CSV / GAMP 5, ISA-95, and data integrity.
- Strong leadership, communication, and stakeholder management skills.
- Based in, or willing to relocate to, St. Louis, Missouri.
- Authorized to work in the US.
Responsibilities
- Lead and drive the MES project end-to-end.
- Act as the senior MES lead and main point of contact for client stakeholders.
- Gather requirements and translate bioprocess manufacturing workflows into MES solutions.
- Oversee MBR / EBR design, configuration, and integration with ERP, automation, and other site systems.
- Ensure compliance with GMP, CSV / GAMP 5, 21 CFR Part 11, and data integrity requirements.
- Coordinate the project team, timelines, risks, and progress reporting.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
