Sterigenics is looking to solve the problem of managing customer validation projects, ensuring compliance with regulatory standards, and providing high-quality services to customers.
Requirements
- Knowledge of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements.
- Experience working with the FDA and/or international requirements for medical devices
- Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer
- Experience in document control to satisfy all ISO 9000 and FDA (or international equivalent) Quality System requirements.
- Strong computer skills
- Experience in writing and executing validation protocols preferred
- ISO 9000 experience a plus
Responsibilities
- Plans, organizes, and coordinates customer validation activities at the facility.
- Writes validation protocols and final reports supplied by the facility.
- Reviews and approves customer or consultant supplied validation or test protocols for execution within the limitation of the facility’s equipment and Sterigenics operating procedures and compliance with current regulatory standards.
- Responsible for the execution of validation protocols and technically driven customer projects, which include but are not limited to the following: Scheduling the project runs, ancillary resources, lab testing and sample handling.
- Cycle programming and preparation of necessary process documents and safety assessments
- Data collection and analysis of temperature and humidity probe data
- Assuring proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples to the appropriate laboratory
Other
- Minimum BA or BS in a science related field (or international equivalent) and/or 4-6 years equivalent experience
- Two (2) to four (4) years of experience in the pharmaceutical, food or medical device industry with GMP/GLP knowledge a plus but not required.
- Customer service and project management experience desired
- Excellent written and verbal communication skills
- Must be able to lift a minimum of 50 lbs (23kg) and perform repetitive bending and lifting motions over a period of time
