Validation Engineer - DeWitt Area

the-pivot-group-careers; DeWitt (MI); On-site; USD 74,000 - 113,000; Full time

Job summary

The Pivot Group Network in DeWitt, MI is recruiting a Validation Engineer to lead validation activities for manufacturing equipment, systems, and processes. You will design, execute, and oversee IQ, OQ, and PQ protocols to ensure GMP compliance and product quality.

We are seeking candidates with 3+ years in validated environments (medical device/pharma) and strong technical writing. Salary ranges from $74,000 to $113,000 depending on experience, with opportunities for growth and impact.

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 device, pharmaceutical).
• Demonstrated knowledge of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with IQ, OQ, PQ, software validation, and process validation.
• Strong technical writing skills for creating and reviewing validation protocols and reports.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, systems, and processes.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements.
• Analyze validation data, generate reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and manage change control processes related to validation.
• Collaborate with R&D, Quality, Manufacturing, and Engineering teams to ensure successful project execution and product launches.
• Maintain validation documentation and ensure audit readiness in accordance with GMP guidelines.
• Support continuous improvement initiatives for validation processes and procedures.

Skills

Regulatory knowledge

Technical writing

Cross-functional collaboration

Risk assessment

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ execution

Validation protocols

Job description

Validation Engineer | DeWitt, MI

Salary Range: $74,000 - $113,000 depending on experience

Are you a seasoned 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 community growth. We are collaborating with leading companies in DeWitt seeking Validation Engineers to lead and enhance their operations.

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 DeWitt 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 and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, systems, and processes.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements.
• Analyze validation data, generate reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and manage change control processes related to validation.
• Collaborate with R&D, Quality, Manufacturing, and Engineering teams to ensure successful project execution and product launches.
• Maintain validation documentation and ensure audit readiness in accordance with GMP guidelines.
• Support continuous improvement initiatives for validation processes and procedures.

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 device, pharmaceutical).
• Demonstrated knowledge of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with various validation activities, including IQ, OQ, PQ, software validation, and process validation.
• Strong technical writing skills for creating and reviewing validation protocols and reports.

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, Test Automation Engineer, Quality Assurance Engineer, QA Validation Engineer, Compliance Engineer, Regulatory Affairs Engineer, GxP Engineer, Software Validation Engineer, Validation Specialist, Technical Validation Engineer, Validation Lead, Validation Consultant

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.