Validation Engineer - Montague Area

the-pivot-group-careers; Montague Township (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network is expanding its West Michigan manufacturing-focused recruiting network with a Validation Engineer opportunity in Montague, MI. The role centers on developing and executing validation protocols for equipment, processes, and systems, ensuring IQ/OQ/PQ activities are completed to meet regulatory expectations.

Ideal candidates hold a Bachelor's degree in engineering or a related field and 3+ years of validated manufacturing experience, with strong knowledge of GxP, FDA

Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years in validation activities within a regulated manufacturing environment.
• Strong understanding of GxP, FDA regulations, and industry standards.
• Experience with validation lifecycle activities, IQ/OQ/PQ protocols and reports.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and systems.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing equipment.
• Conduct risk assessments and develop validation strategies based on regulatory requirements.
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate and resolve deviations and non-conformances during validation activities.
• Maintain validation documentation in accordance with internal procedures and external regulations.
• Support change control activities by assessing validation impact and developing revalidation plans.

Education

Bachelor's degree in engineering or related field

Tools

GxP standards

FDA regulations

ISO 13485

21 CFR Part 820

21 CFR Part 11

Job description

Validation Engineer | Montague, MI

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

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

We are building our network of talent in this field across West Michigan and the broader manufacturing region Pivot Group Network serves. Our partner companies may or may not have an immediate opening for this exact role today, but we actively look for skilled professionals in the regions where they operate. If there is alignment now or in the near future, we reach out.

The Opportunity

We collaborate with manufacturing companies in the Montague 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 for equipment, processes, and systems.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing equipment.
• Conduct risk assessments and develop validation strategies based on regulatory requirements.
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate and resolve deviations and non-conformances during validation activities.
• Maintain validation documentation in accordance with internal procedures and external regulations.
• Support change control activities by assessing validation impact and developing revalidation plans.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years experience in validation activities within a regulated manufacturing environment (e.g., medical device, pharmaceutical).
• Strong understanding of GxP, FDA regulations, and industry standards (e.g., ISO 13485, 21 CFR Part 820, 21 CFR Part 11).
• Proven experience with validation lifecycle activities, including IQ, OQ, PQ protocols and reports.
• Proficiency in statistical analysis and data interpretation for validation purposes.

Bonus Qualifications

• Additional certifications or training

Job Titles That Should Apply

Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Test Engineer, Verification Engineer, Quality Engineer, QA Validation Engineer, Validation Specialist, Validation Lead, Validation Manager

Why The Pivot Group Network

The Pivot Group Network 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. Learn more at https://www.thepivotgroup.org.

The Pivot Group Network 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.