Validation Engineer - Cadillac Area

Validation Engineer | Cadillac, MI

Salary Range: $75,000 - $114,000 depending on experience

Are you a forward-thinking professional with a passion for excelling in validation engineer? The Pivot Group is committed to fostering meaningful relationships in the manufacturing community. We partner with companies in Cadillac seeking skilled Validation Engineers.

The Opportunity

We collaborate with manufacturing companies in the Cadillac region seeking Validation Engineers. These employers partner with us because they want real insight into candidates—not just resumes. By joining our network, you gain access to roles worth considering.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
• Identify and document validation requirements based on product specifications, regulatory guidelines, and risk assessments.
• Conduct data analysis and generate validation reports, summarizing findings and recommending actions.
• Troubleshoot and resolve deviations encountered during validation activities, implementing corrective and preventative actions (CAPAs).
• Maintain validation documentation and ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
• Participate in change control processes, assessing the impact of changes on validated systems and performing revalidation as needed.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Assurance, and Engineering, to ensure successful validation efforts.
• Support regulatory inspections and audits by providing validation documentation and explanations.

Recommended Qualifications

• Bachelor's degree in Engineering (e.g., Electrical, Mechanical, Chemical, Computer) or a related scientific field.
• Proven experience in validation processes (IQ, OQ, PQ) within a regulated manufacturing environment (e.g., pharmaceuticals, medical devices, food & beverage).
• Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and relevant regulatory guidelines (e.g., FDA, EMA).
• Experience with various types of validation, including process, equipment, cleaning, and software validation.
• Proficiency in developing, executing, and documenting validation protocols and reports.
• Familiarity with statistical analysis techniques for data interpretation and validation conclusion.

Bonus Qualifications

• - Experience with statistical process control (SPC) software and analysis.
• - Familiarity with Lean Manufacturing principles and their application in validation.
• - Knowledge of Good Automated Manufacturing Practice (GAMP) guidelines.
• - Experience with root cause analysis (RCA) techniques for deviations.
• - Proficiency in data visualization tools for reporting validation results.

Job Titles That Should Apply

Validation Engineer, QA Engineer, Quality Assurance Engineer, Test Engineer, Software Tester, Verification Engineer, Product Validation Engineer, System Validation Engineer, Process Validation Engineer, Validation Specialist, Quality Control Engineer, Test Automation Engineer, Release 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.