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. Duties and Responsibilities

• Demonstrate skills set, knowledge and apply ASTM E2500 principles, and good engineering practices to the Site Validation Lifecycle concept
• Author, review, and execute commissioning, qualification, validation (CQV) documentation
• Maintain Equipment / Facility / Utility (EFU) and computer validation program in accordance with Validation Master Plans and corresponding SOPs
• Ensure that CQV Validation project deliverables (i.e., Specification, SOPs; Protocols / Reports; Risk Assessment; Traceability Matrix, etc.) are compliant with the current regulations, current industry practices, and internal policies and procedures
• Execute and / or provide support with CQV validation activities of cross functional teams including Process Science / MSAT, Engineering, QC, Manufacturing, and QA as applicable
• Author of valid systems' inventory to maintain periodic review scheduling and revalidation program
• Apply a science and risk-based approach for Process / Lab equipment, Systems qualification activities to assess the need and / or extent of required validation efforts
• Generate and resolve qualification / validation protocol discrepancies and / or other impact investigation incidents
• 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
• Support Quality system elements to include SOPs, CAPAs, Change Controls, Deviations, and Investigations as applicable Qualifications
• Bachelor's Degree in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, etc.), Life Sciences, or related scientific discipline
• 3+ years of hands-on, direct validation experiences in pharmaceutical / biotech industries
• Good understanding of disposable technology preferred
• Recent and relevant Upstream (i.e., single-use Bioreactor) or Downstream (TFF / Chromatography Filtration Systems), Temperature Mapping, Analytical Lab process equipment & computerized system (CSV) validation experiences
• Good knowledge in writing, reviewing, and executing CQV validation protocols and technical reports (including user / functional / design specifications, etc.)
• Working knowledge of applied risk assessment tools (various)
• Ability to work independently and in a team environment to meet defined and assigned objectives based on established timelines and project scope
• Must have experience with cGMPs and Good Engineering Practices Preferred Qualifications
• Familiar, knowledgeable, demonstrate ability to read, comprehend and interpret equipment manuals, P&ID's, mechanical and electrical drawings and PLC logic is a plus
• Strong communication, prioritization, and organizational skills, attention to details

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