Validation Engineer - Caledonia Area

Validation Engineer | Caledonia, MI Salary Range: $73,000 - $112,000 depending on experience Are you ready to take on a challenging and rewarding opportunity in {{role_field}}? The Pivot Group is committed to building meaningful connections in manufacturing. We partner with leading companies in Caledonia seeking Validation Engineers. The Opportunity We are collaborating with multiple companies in Caledonia seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals. Key Responsibilities Develop and execute validation protocols for manufacturing equipment, processes, and software. Document all validation activities, including deviations, investigations, and change controls. Ensure compliance with relevant regulatory requirements (e.g., FDA, GxP) and internal quality standards. Perform IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) testing. Analyze validation data and generate comprehensive validation reports. Collaborate with cross-functional teams (e.g., Engineering, Manufacturing, Quality Assurance) to define validation strategies and requirements. Maintain validation master plans and ensure ongoing compliance through revalidation activities. Troubleshoot and resolve validation-related issues encountered during testing or operation. Recommended Qualifications Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical) or a related scientific field. Proven experience in performing validation activities (IQ, OQ, PQ) for manufacturing equipment and processes. Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, ISO). Experience with developing and executing validation protocols and reports. Knowledge of statistical analysis and data interpretation for validation purposes. Familiarity with change control procedures and deviation management systems. Bonus Qualifications - Experience with statistical process control (SPC) software and methodologies. - Familiarity with Lean manufacturing principles and continuous improvement initiatives. - Knowledge of Good Automated Manufacturing Practice (GAMP) guidelines. - Experience with risk management techniques like FMEA (Failure Mode and Effects Analysis). - Proficiency in scripting languages (e.g., Python, VBA) for automating validation tasks. Job Titles That Should Apply Validation Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Test Engineer, Product Validation Engineer, Software Validation Engineer, Hardware Validation Engineer, Process Validation Engineer, System Validation Engineer, Technical Validation Engineer, Compliance Engineer, Verification Engineer, Automation Test Engineer, Performance Test Engineer Why Pivot Group The Pivot Group 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. 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. The Pivot Group 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.