Validation Engineer - Mason Area

the-pivot-group-careers; Glendale (MI); On-site; USD 72,000 - 111,000; Full time

Job summary

The Pivot Group Network in Michigan is seeking a Validation Engineer to develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, and software. The role involves risk assessment, data analysis, and reporting to cross-functional teams.

Ideal candidates have a Bachelor's degree in engineering, 3+ years of validation experience in regulated manufacturing, and strong knowledge of GxP, FDA/ISO standards, and CSV. Location: Mason, MI with on-site work.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of validation experience in regulated manufacturing (medical device/pharma).
• Strong knowledge of GxP regulations (FDA/ISO).
• Experience with IQ/OQ/PQ and CSV validation lifecycle.
• Excellent technical writing for protocols and reports.

Responsibilities

• Develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software.
• Perform risk assessments and create validation plans per regulatory requirements.
• Analyze data, write reports, and present findings to cross-functional teams.
• Investigate deviations and implement corrective actions during validation.
• Maintain validation documentation and ensure regulatory compliance.
• Collaborate with engineering, quality, and production teams to integrate validation.
• Support change control processes for validated systems.
• Assist in regulatory audits and inspections with documentation.

Skills

Validation experience

GxP compliance

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

MiniTab

JMP

SCADA

PLC

FMEA

Job description

Validation Engineer | Mason, MI

Salary Range: $72,000 - $111,000 depending on experience

Are you a dedicated 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 and supporting career growth. We partner with leading manufacturing companies in Mason, seeking experienced Validation Engineers to strengthen their teams.

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 partner with manufacturers across Mason 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 software.
• Perform risk assessments and generate validation plans in accordance with regulatory requirements (e.g., FDA, ISO).
• Analyze validation data, write comprehensive reports, and present findings to cross-functional teams.
• Investigate deviations and out-of-specification results during validation activities, implementing corrective actions.
• Maintain validation documentation and ensure compliance with internal procedures and external regulations.
• Collaborate with engineering, quality, and production teams to integrate validation activities into the product lifecycle.
• Support the development and implementation of change control processes for validated systems.
• Participate in regulatory audits and inspections, providing documentation and technical 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 and industry standards (e.g., FDA 21 CFR Part 820, ISO 13485).
• Proven experience with validation lifecycle activities including IQ, OQ, PQ, and computer system validation (CSV).
• Excellent technical writing skills for creating 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 software validation (e.g., SCADA, DCS, PLC).
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with risk management tools and techniques (e.g., FMEA, PHA).
• Knowledge of cybersecurity principles as they apply to manufacturing systems.

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 (Validation), QA Validation Engineer, Validation Specialist, Validation Lead, Validation Manager

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.