Sr Sterilization Validations Engineer (Tijuana)

Job Summary

• Work with a significant degree of independence and self-direction to develop, implement, and execute validation related programs in compliance with Centerpiece’s QMS, 21 CFR Section 820, EN ISO 13485, ISO 11135, Environmental Standards, and other operating requirements.
• Work closely with operations and quality teams to ensure adherence to validation projects (budgetary, timeline, etc).
• Generate validation IQ/OQ/PQ protocols, risk assessments, reports, and technical files.
• Routinely interact with 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 ...