Validation Engineer | St. Johns, MI

Salary Range: $73,000 - $112,000 depending on experience

Are you a skilled professional with a passion for excelling in validation engineer? The Pivot Group is dedicated to building meaningful connections in the manufacturing community. We are collaborating with companies in St. Johns seeking experienced Validation Engineers.

The Opportunity

We are working with companies in St. Johns that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key Responsibilities

• Develop, execute, and document validation protocols for manufacturing processes, equipment, and software.
• Conduct risk assessments to identify critical control points and potential failure modes in manufacturing operations.
• Author and maintain validation master plans, validation reports, and change control documentation.
• Troubleshoot and investigate deviations from validated processes and implement corrective and preventative actions (CAPAs).
• Ensure compliance with regulatory requirements (e.g., FDA, GMP, ISO) and internal quality standards.
• Perform revalidation activities and support process improvements based on validation data.
• Train manufacturing personnel on validated procedures and their importance.
• Collaborate with cross-functional teams, including R&D, Engineering, and Quality Assurance, on validation projects.

Recommended Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical, Biomedical) or a related scientific field.
• Proven experience in validation activities within a regulated manufacturing environment (e.g., pharmaceutical, medical device, food & 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.
• Familiarity with risk assessment methodologies (e.g., FMEA) and their application in validation.
• Excellent technical writing, communication, and problem-solving skills.

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 Practices (GAMP) guidelines.
• - Experience with data integrity principles and practices.
• - Proficiency in scripting languages (e.g., Python, SQL) for data analysis and automation.

Job Titles That Should Apply

Validation Specialist, Process Validation Engineer, Software Validation Engineer, Hardware Validation Engineer, Test Engineer, Quality Control Engineer, Automation Test Engineer, System Validation Engineer, Compliance Engineer, Verification 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.