Homebased out of the Sterigenics facility in Los Angeles, CA, the Regional Validation Engineer will report to the facility General Manager. Additionally, they will be a technical representative for the Sterigenics’ Director of Validations. In that role, they will be responsible for helping to ensure the validation procedures and regulatory requirements are met and maintained for the America’s region Sterigenics Ethylene Oxide facilities and its customers. They will also provide management with information and data on all key aspects of each customer’s validation project within the region, which is used by both the plant and the customer to determine the course of routine processing. Must effectively interface with Sales, Operations, Corporate EO Technology, Laboratory, EHS, Quality, Engineering and other Sterigenics’ facilities, as well as customers and regulatory personnel.
EDUCATION REQUIRED
- Minimum BA or BS in a science related field (or international equivalent).
EXPERIENCE AND SKILLS REQUIRED
- Four (4) to six (6) years’ experience in the pharmaceutical, food or medical device industry with GMP/GLP knowledge a plus but not required.
- Direct experience in sterility assurance or products sterilization required.
- Must have experience in writing and executing validation protocols.
- Customer service and project management experience desired.
- ISO 9000 experience a plus.
- Excellent written and verbal communication skills.
- Strong computer skills.
- Forklift driving experience desired.
- Must be able to lift a maximum of 50 lbs. (23kg) and perform repetitive bending and lifting motions over a period of time.
- Must be able to work a flexible schedule including weekends, holidays (if necessary).
SPECIAL REQUIREMENTS
- Position will require travel to other sites (may not only be within their region) – up to 50% annually.
- Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements.
- Understanding of AAMI, EN and ISO guidelines for EO sterilization of medical devices is desirable.
- Knowledge and experience working with the FDA and/or international requirements for medical devices is essential.
- Knowledge of regulatory affairs for FDA (or international equivalent) registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA (or international equivalent) or supplier audits.
- Experience with a company using EO sterilization of products is desirable.
- Experience in document control to satisfy all ISO 13485 and FDA (or international equivalent) Quality System requirements.
- Must be medically approved for respirator use (EO).
- Must be able to tolerate exposure to high temperatures and high humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO).