MES Program Manager – Biopharma Manufacturing

Unicon Pharma Inc; Missouri; On-site; USD 140,000 - 190,000; Full time

Job summary

Unicon Pharma Inc. seeks a senior MES programme leader to own end-to-end delivery from strategy through go-live and hypercare. You will lead MES engineers, coordinate with site leadership, Manufacturing, Quality, MS&T, IT and Automation, and drive ISA-95 aligned designs.

Responsibilities include defining URS and design specs, managing budget and risk, validating test strategies (FAT/SAT/IQ/OQ/PQ), and ensuring GMP, CSV/GAMP 5 and 21 CFR Part 11 compliance. Relocation to St. Louis preferred.

Qualifications

• Degree in chemical / bioprocess engineering, life sciences, computer science or a related discipline.
• 12+ years’ experience in life sciences manufacturing systems, including 5+ years in lead or manager-level MES delivery.
• Deep hands-on expertise with a leading MES platform (e.g., PAS‑X, Syncade, PharmaSuite, Opcenter).
• Solid knowledge of ISA‑95 / ISA‑88 and MES integration with ERP, DCS and LIMS.
• Demonstrated leadership of multi‑disciplinary teams and confident engagement with senior client stakeholders.
• Based in, or willing to relocate to, St. Louis, Missouri, and authorized to work in the US.

Responsibilities

• Lead end-to-end MES programme from strategy through design, build, validation, go-live and hypercare.
• Lead process-mapping and fit-gap workshops, translating workflows into MES designs.
• Define and approve URS, functional and design specifications, MBR/EBR standards, and review-by-exception strategy.
• Set the integration architecture with ERP, DCS, LIMS, historian and other site systems per ISA‑95/ISA‑88.
• Ensure GMP, CSV/GAMP 5, 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity principles.
• Lead, mentor and allocate a team of MES engineers and consultants; manage plan, scope, budget, risks, change control and resource forecasts.
• Direct the test strategy (FAT/SAT/IQ/OQ/PQ), cutover planning, go-live readiness and handover to site support.
• Support account growth through solutioning, estimates and proposals for MES enhancements.

Skills

MES leadership

Stakeholder management

Team leadership

Process mapping

Test strategy design

Regulatory compliance

Education

Chemical/bioprocess engineering OR related

Tools

PAS-X

Syncade

PharmaSuite

Opcenter

Job description

Own end-to-end technical and delivery leadership of the MES programme, from strategy and design through build, validation, go-live and hypercare.

Act as the senior MES authority and primary point of contact for site leadership, Manufacturing, Quality, MS&T, IT and Automation stakeholders.

Lead process-mapping and fit-gap workshops, translating upstream, downstream, media / buffer preparation and weigh & dispense workflows into MES designs.

Define and approve URS, functional and design specifications, MBR / EBR design standards and review-by-exception strategy.

Set the integration architecture with ERP, DCS / automation, LIMS, historian and other site systems in line with ISA-95 / ISA-88.

Ensure solutions comply with GMP, CSV / GAMP 5 (including risk-based / CSA approaches), 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity principles.

Lead, mentor and allocate a team of MES engineers and consultants, setting technical standards and assuring the quality of all deliverables.

Manage plan, scope, budget, risks, change control and resource forecasts, reporting progress to client and AMTSOL leadership.

Direct the test strategy (FAT / SAT / IQ / OQ / PQ), cutover planning, go-live readiness and handover to site support.

Support account growth through solutioning, estimates and proposals for MES enhancements and follow-on phases.

Requirements

• Degree in chemical / bioprocess engineering, life sciences, computer science or a related discipline.
• 12+ years’ experience in life sciences manufacturing systems, including 5+ years in lead or manager-level MES delivery.
• Strong process background in biopharmaceutical / bioprocess manufacturing (upstream and / or downstream) — process engineering, MS&T or operations experience is mandatory.
• Proven delivery of at least one full-lifecycle MES implementation in a GMP environment.
• Deep hands-on expertise with a leading MES platform (e.g., PAS‑X, Syncade, PharmaSuite, Opcenter).
• Solid knowledge of ISA‑95 / ISA‑88 and MES integration with ERP, DCS and LIMS.
• Sound knowledge of GMP, CSV / GAMP 5, 21 CFR Part 11 and data integrity.
• Demonstrated leadership of multi‑disciplinary teams and confident engagement with senior client stakeholders.
• Based in, or willing to relocate to, St. Louis, Missouri, and authorized to work in the US.

Preferred

• Multi‑site MES rollout, upgrade or global template experience.
• PMP, PRINCE2 or equivalent project management certification.