Validation Engineer - Coopersville Area

the-pivot-group-careers; Camden (MI); On-site; USD 79,000 - 119,000; Full time

Job summary

The Pivot Group Network partners with West Michigan manufacturers to connect qualified Validation Engineers with ongoing and upcoming opportunities in Coopersville, MI. This role emphasizes the design, execution, and documentation of IQ, OQ, and PQ validation programs across equipment, processes, and software.

You will assess risks, generate validation plans, and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP while coordinating with R&D, Quality, and Manufacturing teams to drive

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in validation within regulated manufacturing (medical devices, pharma, biotech).
• Proven experience with IQ, OQ, PQ protocols and execution.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, GMP.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze data and author comprehensive validation reports detailing results and conclusions.
• Collaborate with R&D, Quality, and Manufacturing to define validation strategies.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Maintain validation documentation in an organized, retrievable manner.
• Support internal and external audits by providing validation documentation and SME input.

Skills

Risk assessment

Validation execution

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering or related scientific discipline

Tools

IQ/OQ/PQ protocols

Job description

Validation Engineer | Coopersville, MI

Salary Range: $79,000 - $119,000 depending on experience

Are you a skilled professional 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 in the manufacturing community. We are collaborating with companies in Coopersville seeking experienced 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 are collaborating with manufacturing firms in Coopersville 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 equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements.
• Analyze data and author comprehensive validation reports summarizing results and conclusions.
• Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to define validation strategies.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Maintain validation documentation in an organized and readily retrievable manner.
• Support internal and external audits by providing validation documentation and subject matter expertise.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals, biotech).
• Proven experience with IQ, OQ, PQ protocols and execution.
• Strong understanding of relevant industry regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, GMP).
• Experience with equipment, process, and/or software validation.

Bonus Qualifications

• Additional certifications or training

Job Titles That Should Apply

Validation Specialist, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Quality Engineer - Validation, QA Validation Engineer, Validation Consultant, Senior Validation Engineer, Lead 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.

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.