Senior MES Consultant (Biopharmaceutical / Bioprocess Manufacturing)

The Senior MES Consultant will drive the delivery of an MES project within a GMP-regulated bioprocess manufacturing environment, combining strong MES expertise with hands-on bioprocess knowledge to deliver a compliant, robust solution.

Key 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.

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 (e.g., PAS-X, Syncade, PharmaSuite, 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, and authorized to work in the US.