Engineer III, Validation
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
What will you do?
This senior level position will have the following responsibilities:
- Plan and execute validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives.
- Act as a subject matter expert supporting sites during audits and inspections as needed.
- Generate, review and approve departmental documentation (e.g., SOPs, protocols, final reports, data trends). Participate in document revisions, providing input, as necessary.
- Coordinate with stakeholders for validation project initiatives, including protocol generation, execution and closeout.
- Provide leadership and expertise for validation activities during the tech transfer of new products in the manufacturing facility.
- Provide leadership and expertise for the CQV revalidation program for the site.
- Establish and maintain cross-site relationship with other Brammer Bio sites to promote and maintain best practices.
How will you get here?
- A B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical engineering, biology or related engineering/science field and 8 years of appropriate CQV experience in a cGMP manufacturing environment preferred
Knowledge, Skills, Abilities
- Extensive knowledge of validation activities including plan and protocol generation, execution, and final report approval/closeout.
- Understanding and/or knowledge of change control and performing validation impact assessments.
- Strong interpersonal and communication skills.
- Strong technical writing skills.
- Experience with performing facility qualifications, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification).
- Experience with performing equipment qualification activities for the following systems: bioreactors, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.
- Experience with performing utility qualification activities for the following systems preferred: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), CIP, Chilled Glycol, Wastes, etc.
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. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.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.