The Validation Engineer is a dynamic role contributing to developing new products, systems and processes used in manufacturing, testing or quality systems. Establish user requirements, write and execute validation plans, protocols, and reports.
- Act as the Subject Matter Expert for validations within the operations team.
- Implementation of innovative systems and development of activities for compliance with validation principles, federal regulations, guidelines and company policy.
- Analyze and improve on company validation procedures and practices.
- Assess validation requirements for projects and programs. Write reports and follow-up on recommendations to assure that necessary changes are made to existing systems and procedures.
- Review and troubleshoot anomalies, deviations, etc.
- Resolve and consult on complex issues.
- Ensure accuracy and completeness of validation records.
- Align operations documents to facilitate manufacturing, logistical and QA processes.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- BS in Engineering, Life Science or other relevant field of study
- Process validation experience in a regulated industry; medical device preferred
- Excellent quantitative and analytical skills including proficient use of statistical software
- Ability to communicate comfortably with confidence to cross-functionally collaborate
- Strong project management and problem-solving skills.