Engineer III, Validation

Job Description

DUTIES:

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);

Author and 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 relevant sites to promote and maintain best practices.

Travel: Up to 25% domestic and international travel required.

REQUIREMENTS: Master’s degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, Electrical Engineering, Biology, or related field of study. Three years of experience in a cGMP manufacturing environment or related experience. Employer also accepts a Bachelor’s degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, Electrical Engineering, Biology, or related field of study plus 5 years of experience in a cGMP manufacturing environment or related experience.

Required knowledge or experience with:

Validation activities including plan and protocol generation, execution, and final report approval/closeout;

Change control and performing validation impact assessments;

Conducting facility qualifications, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification);

Performing equipment qualification activities for the following systems: bioreactors, mix tanks, chambers, tangential flow filtration (TFF), drug product filler, etc.;

Performing utility qualification activities for the following systems: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), etc.