Thermo Fisher Scientific FEU Validation Program Manager - Global VVS in Lexington, Massachusetts
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Location/Division Specific Information
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. This role provides oversight to four or more sites having significant effect on the organization, complex site(s) and projects.
The role is based at any one of the VVS sites in Massachusetts (Cambridge, Lexington, or Plainville), but time may be spent at all VVS facilities including up to 10% travel to the Alachua, FL facility or other locations.
How will you make an impact?
The Viral Vector Services, Facilities, Equipment and Utilities (FEU) Validation Program Manager will be globally responsible for development of the FEU validation program to assure regulatory compliance across all sites within the VVS network and to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and VVS requirements. They will also be responsible for writing and/or reviewing master validation plans and protocols, onboarding and managing external FEU Validation resources performing validation studies for large and small capital projects at any of the VVS sites.
(S)he creates and maintains relationships with other Thermo Fisher Scientific, Viral Vector Services (VVS) sites to develop and promote FEU best practices and ensures compliance with VVS, safe work practices, GAMP Standards, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.
What will you do?
Perform gap analysis of FEU validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements to VVS sites.
Partner with global data integrity team and Site VALIDATION teams to continuously improve, educate and reinforce data integrity and data management concepts and best practices throughout the systems lifecycle
Partner with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the FEU validation program.
Support site teams during regulatory inspections or client audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
Ensure the successful start-up of a new cGMP FEU systems within viral vector manufacturing facility.
How will you get here?
- BS - Engineering or related field preferred. A combination of education and experience will be considered. HS Diploma or equivalent - required. degree or equivalent in technical area preferred and a minimum of
10 plus years' experience in the development, testing, implementation and validation of FEU systems used by pharmaceutical companies.
Experience with capital project commissioning and qualification and 1-2 years of experience in a project management role desired
Experience providing quality oversight for the development, testing, implementation and validation of computerized systems used within the pharmaceutical industry.
Experience with development of Risk Assessments, URS, DQ, Validation and Test Planning, Development and Execution FEU testing protocols In
Knowledge, Skills, Abilities
Proficient knowledge of FEU system life cycle concepts and global regulations, including FDA cGMP's for the 21st Century, 21 CFR,EudraLex, ISPE Risk Based Approach, ISPE C&Q Guidelines 5, 12, ICH 9, ASTM E2500, GAMP5.
Experience with an enterprise document system such as KNEAT
Fluency in Microsoft Office and database management skills.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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