Validation Engineer - Portage Area

We are partnering with organizations in Portage 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 and execute validation protocols for equipment, processes, and software.
• →Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• →Conduct risk assessments and develop mitigation strategies for validation activities.
• →Analyze validation data and prepare comprehensive reports summarizing results and conclusions.
• →Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality standards.
• →Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• →Investigate and resolve deviations and non-conformances identified during validation.

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience with validation lifecycle activities including IQ, OQ, PQ protocols and reports for equipment, processes, and software.
• Demonstrated ability to author and execute validation documentation effectively.

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., PLCs, SCADA, MES).
• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Demonstrated ability to mentor junior engineers or lead small project teams.
• Experience with specific industry regulations beyond general GMP (e.g., ISO 13485 for medical devices, 21 CFR Part 11 for electronic records).

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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.