MES Implementation Project Manager (6+ Month Contract)

Rentschler Biopharma•Milford, MA
•$45 - $68

About The Position

The MES Implementation Project Manager will lead Rentschler Biopharma Inc.’s implementation of Siemens Opcenter Execution Pharma for GMP buffer manufacturing, weighing and dispensing, and electronic batch records (eBRs). The role partners with functions in Milford, Massachusetts, the MES team in Laupheim, Germany, and Siemens to deliver the approved scope on schedule and within budget, covering requirements, validation coordination, go-live, stabilization, and handover. This is a project delivery role, not ongoing system administration or routine recipe configuration.

Requirements

  • Bachelor’s degree in engineering, information systems, computer science, life sciences, or a related field, or equivalent education and experience.
  • Seven or more years in regulated manufacturing, including three or more years leading cross-functional technology or manufacturing systems projects.
  • Experience delivering MES, eBR, or comparable GMP systems through testing, validation, deployment, and handover.
  • Working knowledge of GMP, computerized system validation, data integrity, electronic records and signatures, and change control.
  • Strong project controls, vendor management, communication, facilitation, and problem-solving skills.
  • Proficiency with scheduling and collaboration tools.

Nice To Haves

  • Siemens Opcenter Execution Pharma experience.
  • SAP and equipment interface experience.
  • Agile or hybrid regulated delivery experience.
  • Multi-site implementation and U.S.–European collaboration experience.
  • PMP or equivalent certification.
  • Experience with super-user development, production cutovers, and support transitions.

Responsibilities

  • Own the integrated schedule, budget, resources, risks, dependencies, change control, and executive reporting; lead a cross-functional matrix team.
  • Coordinate requirements, workflows, acceptance criteria, and configuration delivery, reusing Laupheim templates where appropriate.
  • Manage vendor deliverables and costs, including in-scope SAP integration, master data, scales, label printing, and environment readiness.
  • Partner with Quality and Validation on requirements traceability, testing, defect resolution, data integrity, electronic records and signatures, and release readiness.
  • Coordinate procedures, training, super-users, production-aligned cutover, contingency plans, and go/no-go approvals.
  • Lead stabilization and handover to process, system, and support owners; close with lessons learned and adoption and performance measures.
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