The Sr Sterilization Validations engineer will:
- The Sr Sterilization Validations engineer eventually will work with a significant degree of independence and self-direction to ensure the developing, implementing, and executing validation related programs in compliance with
CENTERPIECE’s QMS and compliant to 21 CFR Section 820, EN ISO 13485, ISO 11135, Environmental Standards, and other as necessary operating requirements.
- The Sr Sterilization Validations engineer will work closely with the operations and quality teams to ensure the adherence to validations projects (budgetary, timeline, etc).
- Generate validation IQ/OQ/PQ protocols, risk assessments, reports, and technical files.
- This position will routinely interact with the production operations team.
- Review risk assessments, commissioning protocols.
- Proven technical experience with demonstrated success in working in a team environment to successfully achieve corporate goals related to new facility and equipment qualification and sterilization validation.
- Must be a strategic, innovative driver of technical solutions, quality implementation, risk management and change with strong technical skills
- Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
- Other duties as assigned
