Validation Engineer | Holland, MI

Salary Range: $72,000 - $111,000 depending on experience

Are you a dynamic leader with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to building meaningful connections and supporting community growth. We are collaborating with leading companies in Holland seeking experienced Validation Engineers to drive results.

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 are collaborating with manufacturing firms in Holland 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 (IQ, OQ, PQ) for manufacturing equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• Analyze validation data, generate reports, and present findings to cross-functional teams.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Support change control activities by assessing the validation impact of proposed changes.
• Maintain validation documentation in an organized and auditable manner.
• Collaborate with R&D, Quality, and Manufacturing teams to define validation strategies.

Recommended Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotechnology).
• Strong knowledge of GxP regulations, FDA guidelines, and industry standards (e.g., ISO 13485, 21 CFR Part 820, Part 11).
• Proven experience in developing, executing, and summarizing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Demonstrated ability to perform risk assessments and root cause analysis.
• Excellent technical writing and communication skills.

Bonus Qualifications

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with GAMP 5 guidelines.
• Knowledge of statistical process control (SPC) and data analysis techniques.
• Certified Quality Engineer (CQE) or similar professional certification.
• Experience with risk-based validation approaches.

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Senior Validation Engineer, Lead Validation Engineer, Principal Validation Engineer

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.

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 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.