Validation Engineer - Grandville Area

the-pivot-group-careers; Grandville (MI); On-site; USD 75,000 - 114,000; Full time

Job summary

The Pivot Group Network in Grandville, MI is seeking a Validation Engineer to develop and execute IQ/OQ/PQ protocols for manufacturing equipment, processes, and systems.

You will analyze data, write reports, support audits, and collaborate with R&D, Quality, and Manufacturing to ensure regulatory compliance and successful product launches.

A Bachelor's degree in engineering and 3+ years of validation experience in regulated environments are preferred.

Qualifications

• Bachelor's degree in engineering or related discipline.
• 3+ years of validation experience in regulated manufacturing.
• Knowledge of GxP regulations such as FDA 21 CFR Part 820, Part 210/211, ISO 13485.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze validation data, write detailed reports, and present findings to cross-functional teams.
• Investigate deviations and non-conformances during validation activities.
• Collaborate with R&D, Quality, and Manufacturing for tech transfer and launches.
• Maintain validation documentation and records.
• Support internal and external audits with validation expertise.

Skills

Validation expertise

Regulatory knowledge

Data analysis

Education

Bachelor's degree in engineering or related field

Tools

IQ/OQ/PQ methodology

Statistical methods

Job description

Validation Engineer | Grandville, MI

Salary Range: $75,000 - $114,000 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 Grandville 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 multiple companies in Grandville seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements (e.g., FDA, ISO).
• Analyze validation data, write detailed reports, and present findings to cross-functional teams.
• Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• Collaborate with R&D, Quality, and Manufacturing teams to ensure successful technology transfer and product launch.
• Maintain and update validation documentation, including master validation plans, procedures, and reports.
• Participate in internal and external audits, providing expert support on validation-related inquiries.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals, biotech).
• Proven knowledge of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485) and industry best practices for validation.
• Experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Strong understanding of statistical methods and their application in validation.

Bonus Qualifications

• Experience with statistical process control (SPC) and design of experiments (DOE)
• Familiarity with cybersecurity principles in manufacturing environments
• Certification in Lean Six Sigma (Green Belt or Black Belt)
• Programming skills (e.g., Python, R, VBA) for data analysis and automation

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Quality Validation Engineer, Senior 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.