International award-winning executive recruitment expert Monroe Consulting Group is recruiting on behalf of a leader in medical devices, is looking for a Sterilization Engineering for the specifying, design, installation and start-up of facility sterilization process and support equipment.
- Develop and validate sterilization processes and equipment in accordance with international standards.
- Develop new equipment operational parameters and instructions, maintenance and calibration procedures. Ensure change control procedures are followed.
- Support or lead validation of equipment installations.
- Review existing equipment procedures, products and materials for gaps and improvement opportunities.
- Support searching out new sterilization modalities and equipment from concept to implementation
- Coordinate validation of sterilization equipment and sterilization of medical devices.
- Provide technical troubleshooting assistance for plant and facilities maintenance technicians.
- Develop project ideas in support of plant cost reduction, quality and maintenance improvement objectives.
- With support from the sterilization team, conduct, review and approve incident investigations. Review corrective actions and develop reliable preventative actions related to sterilization as a result of any nonconformity.
- Assist or lead sterilization qualification projects.
- Develop project scopes, budgets, schedules and prepare documentation.
- Implement projects per approved budget and schedule.
- Education: BS in Chemical, Mechanical, or Electrical Engineering
- 2-3 years of Engineering experience in a Sterilization manufacturing environment.
- Sterilization Technology, Project Management/(Microsoft Project), Mechanical Drawing/(AutoCAD), Microsoft Office programs
Medical device or supplies manufacturing experience preferred.
- Familiar with requirements and standards related to ISO11135, ISO11607 is preferred