Validation Engineer - Lansing Area

the-pivot-group-careers; Lansing (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network in Lansing, MI is seeking an experienced Validation Engineer to partner with leading manufacturing companies. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software, ensuring compliance with FDA, ISO, and industry standards.

You will perform risk assessments, maintain validation documentation, and support audits while collaborating with R&D, Quality, and Manufacturing to drive compliant results.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, ISO 13485) and industry validation standards.
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Familiarity with statistical methods for data analysis and process capability studies.

Responsibilities

• Develop, execute, and review validation protocols and reports (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Collaborate with cross-functional teams to define validation strategies and acceptance criteria.
• Investigate and resolve deviations and non-conformances encountered during validation activities.
• Maintain and update validation documentation, including procedures, master plans, and summaries.
• Provide technical expertise and guidance on validation principles and regulatory expectations to project teams.
• Support internal and external audits by providing validation documentation and responding to inquiries.

Skills

Validation

GxP knowledge

IQ/OQ/PQ

Statistical methods

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

CSV validation

Statistical analysis tools

Job description

Validation Engineer | Lansing, MI

Salary Range: $78,000 - $118,000 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 Lansing 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.

The Opportunity

We are collaborating with multiple companies in Lansing seeking experienced Validation Engineers. These organizations value long-term fit and are looking for professionals who bring both skill and alignment. By joining our network, you gain access to opportunities tailored to your goals.

Key Responsibilities

• Develop, execute, and review validation protocols and reports (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure compliance with regulatory requirements (e.g., FDA, ISO).
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to define validation strategies and acceptance criteria.
• Investigate and resolve deviations and non-conformances encountered during validation activities.
• Maintain and update validation documentation, including procedures, master plans, and summaries.
• Provide technical expertise and guidance on validation principles and regulatory expectations to project teams.
• Support internal and external audits by providing validation documentation and responding to inquiries.

Recommended Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and industry validation standards.
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Familiarity with statistical methods for data analysis and process capability studies.

Bonus Qualifications

• Experience with Computer System Validation (CSV) in an FDA-regulated environment.
• Familiarity with GAMP 5 guidelines.
• Knowledge of statistical methods for data analysis and sampling plans.
• Experience with risk-based validation approaches.
• Certified Quality Engineer (CQE) or similar professional certification.

Job Titles That Should Apply

Validation Engineer, CSV Engineer, Computer System Validation Engineer, Process Validation Engineer, Equipment Validation Engineer, Software Validation Engineer, Validation Specialist, Quality Validation Engineer, Senior Validation Engineer, Lead 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.