Validation Engineer - Kalamazoo Area

the-pivot-group-careers; Kalamazoo (MI); On-site; USD 76,000 - 116,000; Full time

Job summary

The Pivot Group Network seeks an experienced Validation Engineer in Kalamazoo, MI. You will develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes and systems, ensuring regulatory compliance and audit readiness.

You will collaborate with engineering, quality and production teams, perform risk assessments, analyze data, and generate comprehensive validation reports to support lifecycle management and change control.

Qualifications

• Bachelor's degree required in Engineering, Life Sciences, or related technical field.
• 3+ years of validation experience in regulated manufacturing environments (medical device, pharma, biotech).
• Strong understanding of GxP, FDA regulations (21 CFR parts), and ISO standards.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements.
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate deviations or non-conformances identified during validation activities.
• Support lifecycle management of validated systems, including revalidation and change control.
• Collaborate with engineering, quality, and production to ensure project success and compliance.
• Maintain and update validation documentation for audit readiness.

Skills

GxP knowledge

FDA regulations

ISO standards

Statistical methods

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Validation Engineer | Kalamazoo, MI

$76,000 - $116,000 depending on experience

Are you a dynamic leader 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 and supporting community growth. We are collaborating with leading companies in Kalamazoo seeking experienced Validation Engineers to drive results.

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.

We partner with manufacturers across Kalamazoo 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, processes, and systems.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements (e.g., FDA, ISO).
• Analyze validation data, write comprehensive reports, and present findings to cross‑functional teams.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Support the lifecycle management of validated systems, including revalidation and change control.
• Collaborate with engineering, quality, and production teams to ensure successful project execution and regulatory compliance.
• Maintain and update validation documentation to ensure audit‑readiness and adherence to internal 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, biotechnology).
• Strong understanding of GxP, FDA regulations (e.g., 21 CFR Part 820, Part 211, Part 11), and ISO standards (e.g., ISO 13485).
• Proven experience in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Proficiency in statistical methods and data analysis for validation activities.

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

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.