Validation Engineer

Thermo Fisher Scientific - Wilmington, DE (30+ days ago)3.6

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.

  • This role is located in Middletown, VA and includes a full relocation package!
How will you make an impact?

Our Quality department is based on collaboration, and partnership, with all of us working together to support and promote quality across the company. This newly created position will help drive the Quality Validation program for our growing Clinical Diagnostics Division.

What You Will Do

Coordinate validation activities for the Thermo Fisher Scientific Middletown, VA site including evaluation of protocols and data for FDA and ISO purposes.
Prepare and maintain the Validation Master Plan for the plant site.
Identify, schedule, and perform validation studies to meet production, and revalidation requirements.
Evaluate and analyze validation data for accuracy, and adequacy.
Direct validation activities of Production, Engineering, Quality Assurance and other functions.
Drive revalidations for the plant, including writing protocols, performing validation runs, analyzing data, writing reports and assembling final validation packets, and schedule validation runs to meet production goals.
Chairperson for the site Validation Committee.
Assist Quality Assurance, Production and Engineering during inspections or audits.
Assist data summaries for 510K submissions and establishment license applications and updates.
How You Will Get Here
B.S. Degree in Engineering, or scientific discipline
3+ years validation/ quality experience in the biotechnology, pharmaceutical, medical device or in-vitro diagnostics industry.
Experience with validation protocol development, data analysis and report writing.
Experience with process, equipment and software validation principles and concepts.
Who We Are

At Thermo Fisher Scientific, each one of our 55,000 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

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.