Validation Engineer - Caledonia Area

We are partnering with organizations in Caledonia that are seeking Validation Engineers. These companies are committed to building strong teams and are looking for professionals who can lead initiatives effectively. By connecting with The Pivot Group Network, you position yourself for roles that match your background and aspirations.

• →Develop, execute, and review validation protocols and reports for equipment, processes, and software.
• →Perform risk assessments and generate validation plans based on regulatory requirements and industry best practices.
• →Collaborate with cross-functional teams to ensure successful project execution and adherence to quality standards.
• →Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• →Maintain and update validation documentation to ensure compliance with cGMP, FDA, and other regulatory guidelines.
• →Provide technical expertise and guidance on validation strategies and requirements to various departments.
• →Participate in internal and external audits, providing necessary documentation and support.
• →Develop and deliver training on validation principles and procedures to manufacturing and quality personnel.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and international standards (e.g., ISO 13485).
• Proven experience in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical analysis tools and methodologies for validation activities.

• Additional certifications or training

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The Pivot Group Network was founded by manufacturing professionals who've been on both sides of the hiring process. Our clients are strategic—they partner with us because they want real insight into their roles and the people filling them, not a stack of resumes. We focus on match-driven placements built around what actually matters: Commute, Compensation, Culture, and Career trajectory. Learn more at https://www.thepivotgroup.org.

If you're ready to take the next step in your career and connect with a firm that values fit over speed, we invite you to reach out at https://www.thepivotgroup.org. The Pivot Group Network offers resources to support your search—market insights, resume feedback, and interview preparation. As our partnerships grow, we'll reach out with opportunities aligned with your goals. Thank you for considering this approach to career advancement.