About this opportunity
the-pivot-group-careers lists this Validation Engineer - Plainwell Area opportunity in plainwell, Michigan. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Validation Engineer | Plainwell, MI
Salary Range: $79,000 - $119,000 depending on experience
Are you ready to take on a challenging and rewarding opportunity in {{role_field}}? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is committed to building meaningful connections in manufacturing. We partner with leading companies in Plainwell seeking Validation Engineers.
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 partner with manufacturers across Plainwell seeking Validation Engineers who want more than a lateral move. These companies hire intentionally, and we connect them with professionals ready for roles that fit.
Key Responsibilities
Develop, execute, and review validation protocols (IQ, OQ, PQ) for 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, non-conformances, and out-of-specification results during validation activities.
Collaborate with engineering, quality, and production teams to integrate validation requirements into new and existing systems.
Maintain validation master plans, schedules, and documentation in an organized and compliant manner.
Support internal and external audits by providing validation documentation and expertise.
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, biotech).
Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and international standards (e.g., ISO 13485).
Proven experience in developing, executing, and reviewing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
Proficiency in statistical methods and tools for data analysis and validation.
Bonus Qualifications
Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
Familiarity with lean manufacturing principles and Six Sigma methodologies.
Project management certification (e.g., PMP, CAPM).
Proficiency in programming languages for data analysis or test automation (e.g., Python, R, MATLAB).
Advanced degree in a relevant engineering or scientific discipline.
Job Titles That Should Apply
Validation Engineer, QA Validation Engineer, Senior Validation Engineer, Principal Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Cleaning Validation Engineer, Test Engineer, Quality 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
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Worksite address
plainwell, MI, 49080, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.