Validation Engineer - Spring Lake Area

the-pivot-group-careers; Spring Lake (MI); On-site; USD 79,000 - 119,000; Full time

Job summary

The Pivot Group Network in Spring Lake, MI seeks a Validation Engineer to lead validation projects for equipment, processes and software. The role requires hands-on experience with IQ, OQ and PQ, and close collaboration with Quality, Engineering and Manufacturing teams.

The ideal candidate has 3+ years in regulated manufacturing validation, deep knowledge of GxP regulations, and strong technical writing skills for validation documentation.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of validation experience in regulated manufacturing (medical device, pharma).
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Proven experience developing and executing validation protocols (IQ, OQ, PQ).
• Excellent technical writing skills for validation documentation.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data and author validation reports summarizing results and conclusions.
• Investigate deviations and non-conformances during validation activities, implementing corrective actions.
• Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to ensure successful validation.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Support regulatory audits and inspections by providing validation documentation and expertise.

Skills

IQ/OQ/PQ experience

Regulatory compliance

Data analysis

Technical writing

Team collaboration

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

Job description

Validation Engineer | Spring Lake, MI

Salary Range: $79,000 - $119,000 depending on experience

Are you a detail-oriented professional with a passion for excelling in validation engineer? The Pivot Group Network, a West Michigan manufacturing-focused recruiting group, is dedicated to fostering meaningful relationships and supporting career advancement. We are collaborating with leading companies in Spring Lake seeking experienced 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 partnering with organizations in Spring Lake that are seeking Validation Engineers. These companies are committed to building strong teams and are looking for professionals who can lead initiatives effectively. By connecting with The Pivot Group Network, you position yourself for roles that match your background and aspirations.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data and author validation reports summarizing results and conclusions.
• Investigate deviations and non-conformances during validation activities, implementing corrective actions.
• Collaborate with cross-functional teams (e.g., Quality, Engineering, Manufacturing) to ensure successful validation.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Support regulatory audits and inspections by providing validation documentation and expertise.

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 in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Excellent technical writing skills for authoring validation documentation.

Bonus Qualifications

• Familiarity with Six Sigma or Lean Manufacturing principles.
• Experience with statistical analysis software (e.g., Minitab, JMP).
• Knowledge of cybersecurity best practices for industrial control systems.
• Demonstrated ability to mentor junior engineers or lead small project teams.
• Professional certification (e.g., ASQ CQE, CSSBB, PMP).

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, Test Engineer, Verification Engineer, Quality Engineer, QA Engineer, Quality Assurance Engineer, Regulatory Affairs Specialist, Compliance Engineer, Validation Specialist, Validation Lead, Validation Manager, Automation Engineer, 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.