Thermo Fisher Scientific Staff Validation Engineer Team Lead in Middletown, Virginia
Responsible for validation deliverables for projects, participation as an interactive member on Project Teams as a representative of the validation department and lead to all validation engineers. Writes and executes commissioning and validation documents for equipment, instruments, facilities, utilities, and processes utilizing the life-cycle approach, in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports. Participation on various project teams will be required.
Oversee validation engineers and coordinate validation activities for the Thermo Fisher Scientific Middletown, VA site.
Provide guidance and direction for all validation engineers.
Perform, evaluate and analyze validation protocols and associated data for compliance with FDA and ISO guidelines.
Assist with executing to the Validation Master Plan for the plant site.
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.
Ensure qualification plans are in place for all Engineering projects
Determine if external resources are required based on validation project load
Train internal and external validation personnel in all facets of validation activities
Responsible for 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.
Review protocols and studies and provide feedback to Manager
Assist Engineering Team with addressing CAPAs
Act as chairperson for the site Validation Committee.
Review/revise site Validation Procedures.
Represent operations regarding validation during inspections or audits.
Prepare reports and validation summaries for work performed by those other than validation specialists.
Performs other duties as assigned.
Support cleaning validation initiatives to meet regulatory expectations and project timelines.
- B.S. Degree in Engineering or scientific discipline with 2+ 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
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.