Job Description

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.

When youre part of the team at Thermo Fisher Scientific, youll 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 youll be supported in achieving your career goals.

How will you make an impact?

* Provide supervision and guidance for 2 4 engineering professionals within the CQV department.
* 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 management, leadership and expertise for validation activities during the tech transfer of new products in the manufacturing facility.
* Establish and maintain cross-site relationship with other Brammer Bio sites to promote and maintain best practices.

How will you get here?
Education:

* B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical engineering, biology or related engineering/science field

Knowledge, Skills, Abilities

* 10 years of appropriate CQV experience in a cGMP manufacturing environment.

* Minimum 3 years of management experience/direct supervision of staff.

* 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.

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 missionenabling 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.