Validation Engineer - Norton Shores Area

Job Description

Job Description

Validation Engineer | Norton Shores, MI

Salary Range: $78,000 - $118,000 depending on experience

Are you a seasoned professional with a passion for excelling in validation engineer? The Pivot Group is committed to fostering meaningful relationships and supporting community growth. We are collaborating with leading companies in Norton Shores seeking Validation Engineers to lead and enhance their operations.

The Opportunity

We are collaborating with multiple companies in Norton Shores 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 (IQ, OQ, PQ) for manufacturing equipment and processes.
• Author and review validation reports, ensuring compliance with regulatory requirements and company standards.
• Identify and implement improvements to validation strategies and methodologies.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Quality Assurance) to define validation requirements and support project timelines.
• Maintain and update validation documentation, including master validation plans, protocols, and reports.
• Perform change control assessments and manage revalidation activities for modified equipment or processes.
• Conduct risk assessments to identify critical parameters and potential failure modes of equipment and processes.
• Troubleshoot validation deviations and implement corrective and preventive actions (CAPAs).

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 relevant regulatory guidelines (e.g., FDA, ICH).
• Experience with developing and executing validation protocols and reports.
• Familiarity with statistical analysis and data interpretation for validation studies.
• Proficiency in troubleshooting and problem-solving related to manufacturing processes and equipment.

Bonus Qualifications

• - Experience with statistical process control (SPC) software and analysis.
• - Familiarity with Lean Manufacturing principles and their application in validation.
• - Proficiency in root cause analysis methodologies (e.g., 5 Whys, Fishbone diagrams).
• - Experience with automated validation tools and scripting.
• - Knowledge of cGMP regulations specific to the pharmaceutical or medical device industry.

Job Titles That Should Apply

Validation Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Test Engineer, Software Validation Engineer, Hardware Validation Engineer, Process Validation Engineer, System Validation Engineer, Verification Engineer, Product Validation Engineer, Automation Test Engineer, Performance Test Engineer, Reliability Engineer, Regulatory Affairs Specialist

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.