Validation Engineer - Byron Center Area

Validation Engineer | Byron Center, MI

Salary Range: $74,000 - $113,000 depending on experience

Are you a dedicated professional with a passion for excelling in validation engineer? The Pivot Group is committed to fostering meaningful relationships and supporting career growth. We partner with leading manufacturing companies in Byron Center, seeking experienced Validation Engineers to strengthen their teams.

The Opportunity

We partner with manufacturers across Byron Center seeking Validation Engineers who want more than a lateral move. These companies hire intentionally, and we connect them with professionals ready for roles that fit.

Key Responsibilities

• Develop, execute, and document validation protocols for manufacturing equipment, processes, and software.
• Perform IQ, OQ, and PQ (Installation Qualification, Operational Qualification, Performance Qualification) activities.
• Identify and troubleshoot deviations from expected results during validation testing.
• Maintain and update validation documentation, including master plans, protocols, reports, and change controls.
• Ensure compliance with relevant regulatory requirements (e.g., FDA, GMP, ISO).
• Collaborate with cross-functional teams (e.g., Engineering, Manufacturing, Quality Assurance) to define validation scope and requirements.
• Conduct revalidation studies as required due to process changes, equipment modifications, or scheduled intervals.
• Support regulatory inspections and audits by providing validation documentation and explanations.

Recommended Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical, Biomedical) or a related scientific field.
• Proven experience in executing and documenting validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
• Strong understanding of Good Manufacturing Practices (GMP), GAMP 5, and relevant regulatory guidelines (e.g., FDA, EMA).
• Experience with change control procedures and deviation investigations within a regulated manufacturing environment.
• Proficiency in statistical analysis and data interpretation for validation reports.
• Excellent technical writing skills for developing and executing validation plans, protocols, and reports.

Bonus Qualifications

• - Experience with specific industry regulatory bodies (e.g., FDA, EMA, ISO).
• - Proficiency in statistical analysis software (e.g., Minitab, JMP).
• - Familiarity with Good Automated Manufacturing Practices (GAMP).
• - Experience with scripting languages for automation (e.g., Python, PowerShell).
• - Knowledge of specific manufacturing processes relevant to the company's products.

Job Titles That Should Apply

Validation Engineer, Verification Engineer, Test Engineer, Software Validation Engineer, Hardware Validation Engineer, Systems Validation Engineer, Product Validation Engineer, Process Validation Engineer, Quality Assurance Engineer, QA Engineer, Test Automation Engineer, Release Engineer, Compliance Engineer, Validation Specialist, Verification Specialist, Test Specialist, Product Development Engineer, R&D Engineer, Manufacturing 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.