When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
Provides validation support (e.g. validation protocol authorship, testing, execution, and summary) supporting the Steriles business unit and Steriles clients. Works on a variety of validation projects ranging from equipment qualification, cleaning validation, and product validation. Mentors lower level staff as assigned. Performs validation functions to ensure accurate and timely completion of validation responsibilities with frequent decision making, coordination and communications required. Creates, reviews, approves, tracks and presents documents and procedures to both clients and regulatory bodies required for compliance with pharmaceutical regulations as they relate to validation of equipment, processes, and products.
- Prepares, reviews and approves validation documents and rationales. Supports review of manufacturing, filling, and packaging work orders.
- Manages, leads, schedules, executes and tracks multiple validation projects of moderate complexity with multi-disciplinary departments to ensure timely completion of validation deliverables.
- Serves as validation liaison with clients on validation issues. Coordinates, reviews and prepares validation documents.
- Defends validation policies, procedures, rationales and methods during regulatory and client audits.
- Works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements.
- Performs other duties as assigned.
- Bachelor’s degree in a related field is required.
- Four years in the pharmaceutical industry or a regulated industry is preferred.
- Proficient in the use of computerized office applications (e.g. Word, Excel, Outlook) and systems/business applications, project management and demonstrated scientific writing skills.
- Knowledge of cGMPs and FDA/industry expectations. Works on projects of moderate to high complexity in regards to validation within facilities, equipment, manufacturing and support areas.
- Makes decisions in conjunction with other disciplines (e.g. Quality and Production) while taking into account level of risks using written guidance in regards to validation.
- Manage, schedule, execute and track multiple project activities of moderate complexity with multi-disciplinary departments to ensure timely completion of deliverables.
- Demonstrated ability to manage workload in order to achieve goals, evaluate and resolve complex technical problems.
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