Principal Validation Engineer

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 Principal Validation Engineer position at Rentschler Biopharma Inc is a member of Validation Team who demonstrates hands-on experience in developing and executing specifications, operating procedures, commissioning/qualification/validation (CQV) protocols and reports to perform Validation Life cycle of generation, execution, and reports for (DQ, FAT, SAT, IOPQ) of Manufacturing, QC, and Supply Chain process equipment and maintain them in validated state.

This position is responsible for lifecycle qualification of our manufacturing facilities to support concurrent manufacturing operations.

Duties and Responsibilities Maintain Equipment/Facility/Utilities (EFU), Computerized System (CSV) and Cleaning Validation programs in accordance with the Site Validation Master Plan and its corresponding policies and procedures

Lead complex, high-priority validation projects that often require considerable resources and high levels of function integration

Demonstrate skills set, knowledge and apply ASTM E2500 principles, and good engineering practices to the Site Validation Lifecycle concept

Assure good and timely communication of validation projects status and potential issues and/or roadblocks

Work with cross functions or stakeholders to resolve escalations or redirect the project as required

Apply a science and risk-based approach for CQV activities to assess the need and/or extent of required validation efforts

Collaborate with Manufacturing, Engineering, Process Support, Supply Chain, Quality and Regulatory Affairs to ensure that Commissioning Qualification Validation (CQV) project deliverables are compliant with the current regulations, current industry practices, and internal policies and procedures

Provide leadership by training Engineering team members on validation programs and protocol life cycle

Lead Validation Specialists to resolve technical challenges, analyze validation data and coordinate scheduling of qualifications with operational teams

Recommend best practices towards system operation and capital planning based upon validation principles and current industry practicesSME for Validation documents in support of regulatory and client audits

Own Quality System elements to include SOPs, CAPAs, Change Controls, Deviations, and Investigations Perform Annual Product Quality Review for validation of manufacturing systems and processes

Provide expertise in cycle development and validation of complex pharmaceutical manufacturing equipment-cleaning processes

As applicable, perform Validation Life cycle of generation, execution, and reports for (DQ, FAT, SAT, IOPQ) of Manufacturing, QC, and Supply Chain equipment. (Cleaning, temperature mapping, sterilization)
Qualifications Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, etc.), Life Sciences, or related scientific discipline7+ years of hands-on, direct validation experiences in pharmaceutical / biotech industries, including minimum 3 years of managing projects (CAPEX/OPEX)
Champion to adopt / apply principles of ASTM E2500 in CDMO manufacturing operations environment

Must have experience with cGMPs and Good Engineering Practices Excellent…