00 Validation Engineer

We are ZimVie, a 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!

Validation Engineer (Palm Beach Gardens, FL): 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.

Requires a bachelor’s degree in mechanical engineering, electrical engineering, a related field, or foreign equivalent. Requires 3 years of experience in job offered or related field.

Requires 3 years of experience with:

• GxP regulations & state-of-the-art validation techniques used to ensure systems, processes, and equipment that impact product quality and patient safety are consistently compliant and reliable.
• Development, Implementation, and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) system protocols for any system that creates, modifies, maintains, or transmits electronic records/data used in manufacturing, quality control, or documentation.
• Process, equipment and software validation for critical manufacturing processes, automated equipment, and quality-impacting software to prove they consistently meet predetermined specifications including but not limited to equipment such as CNCs, laser markers, packagers, vision systems, ultrasonic cleaning lines, mills, grinders, etc.
• Manufacturing practices including ISO 13485 and 21CFR820 guidelines used to establish, maintain, and ensure the compliance of the Quality Management System (QMS) for devices sold globally and in the U.S.
• Utilizing Statistical Process Control (SPC) Tools (e.g., Minitab) used to analyze validation data (especially for Process Performance Qualification, PPQ runs) to demonstrate process capability (Cpk) and statistical justification for acceptance criteria.
• Utilizing Risk Management Methodology (e.g., ISO 14971) used to formally assess and document risks associated with processes and equipment, which then justifies the scope and rigor of the validation effort.
• Utilizing Qualityze or Similar QMS Platform used to manage and document all controlled quality records, including Change Controls, Non-Conformances (NCs), and Corrective and Preventive Actions (CAPAs) that often stem from validation activities.

Any applicant who is interested in this position may apply to Biomet 3i, LLC via email at hroperations@zimvie.com (please reference job #3517).

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: 3517