Validation Engineer - IQ/OQ/PQ Specialist

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

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.