Validation Engineer - Cadillac Area

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

Job summary

The Pivot Group Network is recruiting a Validation Engineer for Cadillac, MI. This role focuses on developing and executing IQ/OQ/PQ validation protocols for equipment, processes and software within a regulated manufacturing setting.

Ideal candidates bring 3+ years of validation experience, strong knowledge of GxP regulations, and proven skills in technical writing and data analysis. The position emphasizes quality and compliance in a manufacturing environment in West Michigan.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years of validation experience in regulated manufacturing.
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with IQ, OQ, PQ for equipment, processes and software.
• Excellent technical writing for validation protocols and reports.

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.
• Ensure compliance with regulatory requirements (FDA, GMP) and internal standards.
• Investigate deviations and implement CAPAs related to validation activities.
• Support change control by assessing validation impact and revalidation.

Skills

IQ/OQ/PQ validation

Risk assessment

Data analysis

Regulatory compliance

Technical writing

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

PLC

SCADA

Job description

Validation Engineer | Cadillac, MI

Salary Range: $75,000 - $114,000 depending on experience

Are you a forward-thinking 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 in the manufacturing community. We partner with companies in Cadillac seeking skilled 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 working with companies in Cadillac 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.
• Ensure compliance with regulatory requirements (e.g., FDA, GMP) and internal quality standards.
• Investigate deviations and implement corrective and preventive actions (CAPAs) related to validation activities.
• Support change control activities by assessing validation impact and executing necessary revalidation.

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).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Proven experience with validation activities including IQ, OQ, PQ for equipment, processes, and software.
• Excellent technical writing skills for authoring and reviewing validation protocols and reports.

Bonus Qualifications

• Experience with statistical process control (SPC) and data analysis tools (e.g., Minitab, JMP).
• Familiarity with automation systems and control technologies (e.g., PLCs, SCADA).
• Knowledge of cybersecurity principles as applied to manufacturing systems.
• Certified Quality Engineer (CQE) or similar professional certification.
• Experience with Lean Manufacturing or Six Sigma methodologies.

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, Validation Lead, Validation Consultant, QA Validation Engineer, Quality Assurance Validation Engineer, Compliance 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.