Validation Engineer - Hart Area

Validation Engineer | Hart, MI

Salary Range: $81,000 - $121,000 depending on experience

Are you a detail-oriented professional with a passion for excelling in validation engineer? The Pivot Group is dedicated to fostering meaningful relationships and supporting career advancement. We are collaborating with leading companies in Hart seeking experienced Validation Engineers.

The Opportunity

We are collaborating with manufacturing firms in Hart that are seeking skilled Validation Engineers. These organizations are dedicated to maintaining high standards and are looking for professionals who can contribute effectively. By joining our network, you position yourself for opportunities aligned with your career goals.

Key Responsibilities

• Develop and execute validation protocols for manufacturing processes, equipment, and software.
• Document all validation activities, including protocol design, execution, and final reports.
• Identify and assess potential risks associated with manufacturing processes and equipment.
• Troubleshoot and resolve validation deviations and non-conformances.
• Ensure compliance with relevant regulatory guidelines (e.g., FDA, GMP, ISO).
• Collaborate with cross-functional teams (e.g., Engineering, Quality Assurance, Production) to define validation requirements.
• Perform re-validation activities as required due to changes or scheduled intervals.
• Maintain and update validation documentation and databases.

Recommended Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical, Industrial) or a related technical field.
• Proven experience in validation activities within a regulated manufacturing environment (e.g., pharmaceutical, medical device, food and beverage).
• Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and relevant regulatory guidelines (e.g., FDA, EMA).
• Experience with developing, executing, and documenting validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
• Proficiency in risk assessment methodologies (e.g., FMEA) and their application to validation strategies.
• Excellent technical writing skills for creating clear, concise, and accurate validation documentation.

Bonus Qualifications

• - Experience with statistical process control (SPC) methodologies.
• - Familiarity with FDA regulations (e.g., 21 CFR Part 11, Part 820) or other relevant industry standards.
• - Proficiency in programming languages like Python for scripting and data analysis.
• - Experience with automation testing frameworks.
• - Knowledge of Lean Manufacturing principles.

Job Titles That Should Apply

Validation Engineer, QA Engineer, Quality Assurance Engineer, Test Engineer, Software Tester, System Tester, Product Tester, Verification Engineer, Release Engineer, Automation Engineer, Test Automation Engineer, Reliability Engineer, Performance Tester, Integration Tester, Functional Tester, Regression Tester, UAT Tester, Acceptance Tester, Software Quality Engineer, Test Automation Specialist, Software 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.