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 practices
• SME 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 discipline
• 7+ 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 technical writing ability for technical and compliance reports or submission
• Experience in managing multiple projects and leading cross-functional project teams desired
• Detailed knowledge of disposable technology preferred

Preferred Qualifications

• Working experience with the contract development manufacturing and sterile / aseptic operations with a demonstrated knowledge of the general operation of pharmaceutical manufacturing and testing equipment
• Strong communication, prioritization, and organizational skills, attention to details

____________________________________________________________________________ Base Pay Range

$140,000 - $170,000

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated 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 annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.