MES Implementation Project Manager (6+ Month Contract)
Rentschler Biopharma
Summary
The MES Implementation Project Manager will lead the Rentschler Biopharma Inc. implementation of Siemens Opcenter Execution Pharma for GMP buffer manufacturing, weighing and dispensing, and electronic batch records (eBRs). Partner with Milford, MA functions, the Laupheim, Germany MES team, and Siemens to deliver the approved scope on schedule and within budget; from requirements through validation coordination, go-live, stabilization, and handover. This is a project delivery role, not ongoing system administration or routine recipe configuration.
Job description
Key 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/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.
Required Qualifications
- 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/signatures, and change control.
- Strong project controls, vendor management, communication, facilitation, and problem-solving skills; proficiency with scheduling and collaboration tools.
Preferred Qualifications
- Siemens Opcenter Execution Pharma
- SAP and equipment interfaces
- Agile/hybrid regulated delivery
- Multi-site implementation and U.S.-European collaboration
- PMP or equivalent certification
- Super-user development, production cutovers, and support transitions
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
- 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/signatures, and change control
- Strong project controls, vendor management, communication, facilitation, and problem-solving skills
- Proficiency with scheduling and collaboration tools
Company overview
Rentschler Biopharma is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical services. Founded in 1872 and now in its fifth generation as a family-owned company, Rentschler Biopharma has over 50 years of experience in biopharmaceutical manufacturing. The company operates from two main sites: its headquarters in Laupheim, Germany, and a facility in Milford, Massachusetts, USA. With approximately 1,400 employees, Rentschler Biopharma offers comprehensive full-service solutions for bioprocess development and manufacturing of complex biopharmaceuticals, including analytical development, process development, formulation development, cGMP manufacturing, and regulatory affairs consulting. The company has an impressive track record, having contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023 and serving over 180 clients worldwide since 1997. Rentschler Biopharma specializes in complex molecules, with more than 50% of their modalities being complex proteins including advanced antibody formats and recombinant enzymes. The company is known for its reliability, quality management systems, and operational excellence philosophy that ensures product quality and productivity at every development and manufacturing stage.