Job Description – Manager, Validation Engineering Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to join our team and help lead our organization into the future. How will you make an impact? The Validation Manager will own the overall strategy of the site Process engineering team, ensuring that the process engineering group maintains a key figure in driving tech transfers and site projects. The Manager will provide engineering leadership, mentorship, and will work closely with the Validation and Manufacturing teams. What will you do? Ensure all equipment and system design documentation is organized and meets cGMP regulatory standards. Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or interpersonal metrics. Establish and detail the Plainville platform for client processes, enabling rapid tech transfers from clients to the site, while owning equipment readiness for all customer programs, including the generation of utilization heat maps and critical risk registers for all assets on site. Organize and lead ad hoc multi-functional teams to run investigations and implementation of changes. Drive continuous improvement and operational excellence through correcting processes and systems and instilling strong ownership and accountability. Ensure high levels of communication with team; Proactively identify and raise key risks and issues to system owners Drive technical leadership, program management and clients to implement product / process improvements; participates and/or may lead multi-functional projects. Acts as Engineering authority for assessments for change controls, validation protocols, and document changes. Generate, review and approve departmental documentation (e.g., SOPs, protocols, final reports, data trends). Plan, schedule, and resource with team members for validation project initiatives, including protocol generation, execution and closeout Drive validation activities during the tech transfer of new products in the manufacturing facility, including the development of validation plans. Develop and maintain Requalification program for the site Support client and regulatory audits Establish and uphold cross-site relationships with other Thermo Fisher Scientific sites to develop and sustain collaboration and standard processes. How will you get here? Education: Bachelor's degree in Engineering or related field – required. Master’s degree or PhD – desired.