Validation Engineer
4 days ago
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.
Principal Duties and Responsibilities:
- 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
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
- 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.
Education/Experience Requirements
- 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.
Travel Requirements
Up to 10%.
Required.
ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.
ZimVie generally does not sponsor applicant work visas for this position.
- Requisition ID: [[id]]
ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.
ZimVie generally does not sponsor applicant work visas for this position.
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