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.
- Coordinate validation activities for the Thermo Fisher Scientific Middletown, VA site, under the guidance of supervisor and validation engineers.
- Perform, evaluate and analyze validation protocols and associated data for compliance with FDA and ISO guidelines.
- Draft and execute validation protocols, create and execute engineering studies, write SOPs/WIs, etc.
- Identify, schedule and perform validation studies to meet production and revalidation requirements for the plant site.
- Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements.
- Perform routine revalidations 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.
- Review/revise site Validation Procedures.
- Take initiative to identify and resolve any gaps in validation process.
- Work on multiple projects and initiatives simultaneously with shifting priorities.
- Assist in training of staff involved in validation activities.
- Assist QA, Production and Engineering personnel during inspections or audits.
- Prepare reports and validation summaries for work performed by those other than validation specialists.
- Performs other duties as assigned.
- B.S. Degree in Engineering or scientific discipline or 5+ years validation experience in the pharmaceutical or medical device industry performing the tasks listed above.
- Normal office and manufacturing environment.
- Position may require frequent communication and walking to other areas in which designated PPE will be required.
- Position will require sitting and standing.
- Employee may occasionally lift and/or move up to 10 pounds.
Non-Negotiable Hiring Criteria:
- Influence and coordinate activities of personnel over which he/she has no direct authority
- Strong organizational skills
- Work independently with minimal supervision
- Effectively communicate with all levels of the organization from the General Manager to the production operators
- Must be proficient with Microsoft Office
- Travel will be required to support multiple projects.
This position is not approved for relocation benefits.
At Thermo Fisher Scientific, each one of our 50,000 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.