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.
Interface with Director of Validations to strategically plan and prioritize new and existing projects.
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
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)
