Sterigenics is looking to solve the problem of ensuring validation procedures and regulatory requirements are met and maintained for the America's region Sterigenics Ethylene Oxide facilities and its customers.
Requirements
- Direct experience in sterility assurance or products sterilization required.
- Must have experience in writing and executing validation protocols.
- ISO 9000 experience a plus.
- Strong computer skills.
- 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.
Responsibilities
- Assist facilities on site/remotely in project planning and execution of facility/EAS projects to meet turn time.
- Mentor and train current and existing validation personnel in conjunction with their direct managers.
- Perform Root Cause Analysis / Kaizen events with facilities to promote continuous improvement.
- Writes validation protocols and final reports for the facility/EAS.
- 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.
- Assures that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST.
Other
- Minimum BA or BS in a science related field (or international equivalent).
- Four (4) to six (6) years' 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 work a flexible schedule including weekends, holidays (if necessary).
