When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions.

LOCATION/DIVISION SPECIFIC INFORMATION

At the Plainville MA site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies

HOW WILL YOU MAKE AN IMPACT?

The Validation Manager will be the owner of the Commissioning, Qualification and Validation (CQV) program for the site and SME for all qualification activities. The role is responsible for cGMP compliance of facility, utilities, and equipment validations from development thru execution and approval of all validation records and equipment lifecycle documentation policies and procedures supporting current Good Manufacturing Practices. The initial focus of the position will be supporting the execution of a large capital facility project from construction and operational readiness activities for a state-of-the-art new commercial manufacturing facility. This role will transition into primary manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing, laboratory, and warehouse operations.

WHAT WILL YOU DO?

In operations, the Validation Manager is responsible for providing

• Guardianship of all CQV activities for the support of clinical and commercial drug substance manufacturing of cell and gene therapy products
• Identify any areas where non-compliance or non-harmonization is occurring
• Manage/perform the execution, review/approval of design and commissioning documentation, validation protocols, reports, and support records
• Participate in deviation investigations and supports change control assessments and reviewing/approving change control implementation plans related to manufacturing process and associated equipment
• Support internal and external inspections for the subject matter
• Helps drive continuous quality system improvements
• Coordinates contractors/consultants in the day to day execution of CQV scope and projects
• Develops, monitors, and reports performance metrics
• Crafts and maintains CQV SOPs, Validation Master Plans and protocols Requalification program development and
• Builds and manages relationships with other VVS sites to develop and promote validation best practices and ensures compliance with Thermo Fisher (PCG/VVS) SOP’s, safe work practices, and cGMP regulations.
• The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.

HOW WILL YOU GET HERE?

Education

A B.S. Degree required, preferably in an engineering discipline or related technical field.

Experience and Skills

• Minimum of 6 years of relevant validation experience
• Minimum of 2 years in a leadership related role
• Direct experience supporting pharmaceutical manufacturing processes within an FDA/EMA environment is highly desired
• Understanding of validation processes for documentation, equipment, and processes within the pharmaceutical industry
• Experience in authoring, execution, performing, and summarizing documents including URS, SIA, QP, DQ, IQ, OQ, PQ, CSV & QSR and CAPA management

Knowledge, Skills, Abilities

• Strong understanding of applicable regulatory requirements
• Documentation review and revision experience
• Strong interpersonal and communications skills; written and oral
• Working with both on-site and remote based staff
• Comfortable supporting concurrent issues and working in an exciting, ambitious, and fast-paced environment
• High ethical standards to support a professional business code of conduct

Accessibility/Disability Access

ThermoFisher Scientific offers accessibility service for job seekers requiring accommodations during the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation during the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building an exciting career with us.

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.