Validation Engineer - Allegan Area

the-pivot-group-careers; Michigan; On-site; USD 72,000 - 111,000; Full time

Job summary

The Pivot Group Network in Allegan, MI is seeking a Validation Engineer to lead validation activities for equipment, processes, and software. The role emphasizes adherence to regulatory standards and high-quality documentation.

Ideal candidates will have 3+ years in validation within regulated manufacturing, familiarity with FDA/GxP, and experience in IQ/OQ/PQ protocols, data analysis, and report generation.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline is required.
• 3+ years of validation experience in a regulated manufacturing environment.
• Understanding of GxP, FDA regulations, and ISO 13485 is preferred.
• Experience authoring and executing validation protocols for equipment, processes, and software.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data, write validation reports, and present findings.

Skills

GxP knowledge

Regulatory awareness

Statistical analysis

Education

Bachelor's degree in engineering or related field

Tools

MiniTab

R

Python

Job description

Validation Engineer | Allegan, MI

Salary Range: $72,000 - $111,000 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 Allegan 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 are working with companies in Allegan that are adding Validation Engineers to their teams. These organizations value quality over speed in hiring. By connecting with us, you position yourself for opportunities that align with what you're looking for.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data, write validation reports, and present findings.
• Investigate deviations and non-conformances during validation activities.
• Ensure compliance with regulatory requirements (e.g., FDA, ISO) and internal quality systems.
• Collaborate with cross-functional teams including R&D, manufacturing, and quality assurance.
• Maintain validation documentation throughout the equipment and process lifecycle.

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 understanding of GxP, FDA regulations, and industry standards (e.g., ISO 13485).
• Experience authoring and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical analysis and data interpretation for validation activities.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., MiniTab, R, Python).
• Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt certification.
• Familiarity with Computer System Validation (CSV) principles and GAMP 5.
• Experience with risk management tools and methodologies (e.g., FMEA, PHA).
• Knowledge of cybersecurity best practices for industrial control systems.

Job Titles That Should Apply

Validation Engineer, QA Validation Engineer, Computer System Validation Engineer, CSV Engineer, Automation Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Quality Assurance 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.