Job Description

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

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.

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

____________________________________________________________________________ Base Pay Range

$45/hr - $68/hr

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated equivalent annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The salary pay range is subject to change and may be modified at any time.