Validation Engineer - Kentwood Area

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

Job summary

The Pivot Group Network in Kentwood, 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 validation reports, and support lifecycle management while coordinating with engineering, quality, and production to ensure regulatory compliance (FDA/ISO/GxP).

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• 3+ years of validation experience in a regulated manufacturing environment (e.g., medical device, pharmaceutical, biotech).
• Strong understanding of GxP regulations (e.g., 21 CFR Part 820, Part 210/211, ISO 13485) and industry guidance (GAMP 5, ICH Q7, Q9, Q10).
• Experience in developing, executing, and summarizing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical methods and data analysis for validation activities.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements (FDA, ISO).
• Analyze validation data, write validation reports, and present findings to cross-functional teams.
• Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• Support lifecycle management of validated systems, including revalidation and change control.
• Collaborate with engineering, quality assurance, and production teams to ensure successful project implementation and ongoing compliance.
• Maintain and update validation documentation with accuracy and completeness.

Skills

Regulatory compliance

Data analysis

Cross-functional collaboration

Statistical methods

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Minitab

Python

Job description

Validation Engineer | Kentwood, MI

Salary Range: $75,000 - $114,000 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 Kentwood 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 are collaborating with manufacturing firms in Kentwood 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 manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements (e.g., FDA, ISO).
• Analyze validation data, write comprehensive validation reports, and present findings to cross-functional teams.
• Investigate and resolve deviations, non-conformances, and out-of-specification results during validation activities.
• Support the lifecycle management of validated systems, including revalidation, periodic reviews, and change control.
• Collaborate with engineering, quality assurance, and production teams to ensure successful project implementation and ongoing compliance.
• Maintain and update validation documentation, ensuring accuracy, completeness, and adherence to established procedures.

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 regulations (e.g., 21 CFR Part 820, Part 210/211, ISO 13485) and industry guidance (e.g., GAMP 5, ICH Q7, Q9, Q10).
• Proven experience in developing, executing, and summarizing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical methods and data analysis for validation activities.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and software (e.g., PLCs, SCADA, MES).
• Certification in Lean Six Sigma (Green Belt or Black Belt).
• Project management experience or certification (e.g., PMP).
• Proficiency in programming languages relevant to automation or data analysis (e.g., Python, R).

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, Software Validation Engineer, Validation Specialist, QA Validation Engineer, Validation Lead, Validation Consultant, Validation Analyst

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.