Sterilization Specialist (Global role)
Position Summary:
Seeking an experienced Sterilization contractor to support client's manufacturing plants with sterilization strategy, validation, and environmental monitoring. This role will act as sterilization technical resource across sites, lead validation activities for new sterilizers, support audits, and help build a permanent global sterilization capability.
Key Responsibilities:
- Serve as the go-to sterilization contact for manufacturing sites (Trumbull and other plants)
- Develop, review, and author sterilization protocols, validation reports, and related documentation
- Manage environmental monitoring programs related to sterilization processes
- Support internal and supplier audits and work with supplier quality as needed
- Liaise with regulatory, quality, and plant operations on sterilization questions and issues
- Help define requirements and scope for building a dedicated sterilization department/team
- Mentor or lead other technicians/engineers if applicable; assist in hiring/building the team
Required Qualifications:
- Hands-on experience with multiple sterilization modalities (EtO, gamma, dry heat, hard/soft cycles, etc.)
- Proven experience performing sterilization validations and environmental monitoring
- Ability to work under pressure and manage multiple concurrent projects
- Strong technical writing skills for protocols and validation documentation
- Experience supporting audits and interfacing with regulatory/quality teams
Preferred Qualifications:
- Prior experience in medical device or regulated manufacturing environments
- Experience with supplier qualification and supplier audits
Pay:
$40.00
00 per hour Expected hours: 40.0 per week
Experience:
Pharmaceutical Industry:
5 years (Preferred)
Sterilization:
5 years (Preferred)
Work Location:
In person