R

Rentschler Biopharma

CDMO delivering biopharmaceutical development and manufacturing

MES Implementation Project Manager

Project ManagementPosted on Nov 13
Full-timeMilford, MA, USA$45 - $68 /hrIn-person

About the Job

Requirements

  • A bachelor's degree in engineering, information systems, computer science, life sciences, or a related field, or equivalent education and experience.
  • Seven or more years of experience 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.
  • Proficiency with scheduling and collaboration tools.

Responsibilities

  • Own the integrated schedule, budget, resources, risks, dependencies, change control, and executive reporting, and 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.

Desired Qualifications

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

About the Company

Rentschler Biopharma

CDMO delivering biopharmaceutical development and manufacturing

What the company does: Rentschler Biopharma provides contract development and manufacturing services for biopharmaceuticals, helping other pharmaceutical companies develop and produce complex medicines. How its products work: It offers end-to-end services in biopharma development and manufacturing, backed by facilities and staff that design, optimize, and produce biologic drugs at scale for clients, including a major site in Milford, MA that has expanded capacity to serve the international market. How it differs from competitors: It has a long heritage in biopharma, a dedicated CDMO focus since 1997, and a global footprint with a major U.S. site and expanded capacity, positioning itself as a reliable partner for developing and manufacturing complex biologics. What its goal is: To be a trusted partner for pharmaceutical companies by providing development and manufacturing services at scale, supporting clients as they bring biologic medicines to market.

Company size
501-1,000
Company stage
Series A
Total funding
$1.6M
Headquarters
Laupheim, Germany
Founded
1927

Recently Posted Jobs

Explore more opportunities at Rentschler Biopharma

See more jobs