We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients' smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves - their best selves - to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future for ZimVie - we hope you'll consider being a part of it!

Job Summary:

The purpose of this position is to lead, review, and maintain validation planning, validation logs, validation periodic reviews, risk assessment, validation related changes, and investigations into complaints and non-conformances that may contribute to altering the validated state of our processes. The person will act as a process validation SME. As such, the incumbent must be technically competent in various manufacturing processes.

• Develop and execute a comprehensive periodic review program for validated systems and processes, including equipment, software, and manufacturing processes.
• Conduct thorough reviews of validation documentation, including validation plans, protocols, reports, and change controls.
• Assess the continued suitability, adequacy, and effectiveness of validated systems and processes.
• Identify and document potential risks or deviations from established validation requirements.
• Recommend corrective and preventive actions to address identified issues.
• Enact measures and reviews to ensure systems, once validated, remain in a validated state throughout their life cycle.
• Assess the need for revalidation activities or supplemental validation.
• Stay up to date with relevant regulatory requirements (e.g., FDA, ISO 13485) related to validation and periodic review.
• Ensure compliance with internal quality management systems and procedures.
• Collaborate with cross-functional teams to implement and maintain a robust validation program

• Able to work well with others and interact effectively with all levels, outside contacts and support personnel.
• Must manage conflict effectively with all areas of the business.
• Knowledge and understanding of GxP regulations, state of the art validation techniques.
• Must be able to develop, implement, and execute system protocols.
• Advanced knowledge of process, equipment, and software validation
• Must be familiar with Good Manufacturing Practices, ISO 13485 and 21CFR820 guidelines.
• Excellent written and verbal communication skills.
• Strong attention to detail and problem-solving abilities.

• Typically requires bachelor's degree in engineering (Mechanical, Biomedical, Electrical, or related field) or relevant combination of education and equivalent experience.
• 3-5 years' experience in engineering roles.
• Experience managing validations is required.

• Requisition ID: 2924