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.
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 will you do?
- Coordinate validation activities for the Thermo Fisher Scientific Middletown, VA site.
- Perform, evaluate and analyze validation protocols and associated data for compliance with FDA and ISO guidelines.
- 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 collected during projects, verify the adequacy of the data and compliance with regulatory requirements.
- Direct validation activities of production, engineering, Quality Assurance and other function areas related to validation projects.
- Drive the performance of all routine revalidations on schedule for the plant site, including writing protocols, performing validation runs, analyzing data, writing reports and assembling final validation packets.
- Schedule validation runs to meet production and revalidation requirements.
- Act as chairperson for the site Validation Committee.
- Review and revise site Validation Procedures.
- Assist in training of all involved in validation activities.
- Assist Quality Assurance, Production and Engineering employees during inspections or audits.
- Assist in the generation and organization of records, reports and data summaries for 510K submissions and establishment license applications and updates.
- Prepare reports and validation summaries for work performed by those other than validation specialists.
- B.S. Degree in Engineering or scientific discipline
- A minimum of 3 years validation 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
- A high level of expertise concerning current validation principles and regulatory requirements.
- Proficient in statistical analysis and process control.
- Able to influence and coordinate activities with employees without direct authority.
- Able to effectively communicate with all levels of the organization.
- Strong Organizational Skills.
- Able to resolve conflicts between product requests for process change and the validation requirements for those processes.
- Certified Quality Engineer certification preferred.
- Must be proficient with various P.C. software.
This position has been approved for relocation assistance.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.