Senior MES Consultant (Biopharmaceutical / Bioprocess Manufacturing)

Advanced Manufacturing Tech Solutions (AMTSOL) • St. Louis, MO

1d

About The Position

The Senior MES Consultant will drive delivery of an MES project within a GMP-regulated bioprocess manufacturing environment. The role combines 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior