Process Engineer (Contract)

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. 

Duties and Responsibilities 

• Participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment
• Create and review project documents such as URS, P&ID’s, PFD’s, heat and mass balances, etc
• Provide support to validation for the commissioning and qualification of new equipment or improved processes
• Support the development and review of mass balances, PFDs and PIDs, for incoming processes and specify equipment to fulfill process operations
• Define alternatives for BOM components if availability is an issue
• Integrate with Process Sciences, MSAT, Quality, Facilities and Manufacturing teams for successful integration and startup of new processes / equipment at the Milford site
• Review/assess equipment for Data Integrity requirements
• Support investigations for process deviations
• Support asset replacement lifecycle program by leading the implementation of process and process utility equipment to ensure robust manufacturing operations
• Report to project and program leadership on timelines, and technical aspects of project 

Qualifications 

• B.S. in Life Sciences Field (Biomedical, Chemical or Mechanical Engineering preferred)
• 3+ years direct experience in the biopharmaceutical industry
• Experience with cGMP Manufacturing and Good Engineering Practices including electronic signatures and data integrity
• Strong working knowledge of Bioprocess Equipment (Ultrafiltration, Chromatography, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reactor Vessels, etc.)
• Experience with Single Use Technology / Single Use Processing equipment
• Knowledge of cGMP manufacturing in the detailed operations of Upstream and Downstream mAb equipment
• Knowledge of laboratory and pharmaceutical production equipment including conventional and single-use technology, autoclaves, process tanks, bioreactors, aseptic technique, clarification filters, chromatography skids and columns, UF/DF equipment, and analytical equipment
• Must have experience in collaborating within a multi-functional environment to author technical procedures, batch records, forms, deviation documentation and change control documents
• Experienced with troubleshooting approaches (problem statement, root cause analysis, FMEA, fish-bone diagrams, “5 whys”, etc.)
• Excellent interpersonal and communication skills (verbal and written)
• Demonstrated technical writing skills
• Knowledge of basic chemical and biological safety procedures
• Good computer skills: Use of Microsoft software (Word, Excel, Powerpoint, and Project). Familiar with Enterprise Resource Planning (ERP) systems – SAP preferred
• Operational knowledge of clean utility systems including WFI Generation and Distribution, Transfer Systems, CIP Skids, cleaning cycle development

Working Conditions

• Normal office working conditions: computer, phone, files, fax, copier
• Occasional support of the operation of equipment used in biomanufacturing
• Personal Protective Equipment must be worn as required
• Work in clean rooms

Physical Requirements

• PPE as required