Validation Engineer — IQ/OQ/PQ Specialist

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

Job summary

The Pivot Group Network partners with West Michigan manufacturers to connect qualified Validation Engineers with ongoing and upcoming opportunities in Coopersville, MI. This role emphasizes the design, execution, and documentation of IQ, OQ, and PQ validation programs across equipment, processes, and software.

You will assess risks, generate validation plans, and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP while coordinating with R&D, Quality, and Manufacturing teams to drive

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in validation within regulated manufacturing (medical devices, pharma, biotech).
• Proven experience with IQ, OQ, PQ protocols and execution.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, GMP.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze data and author comprehensive validation reports detailing results and conclusions.
• Collaborate with R&D, Quality, and Manufacturing to define validation strategies.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Maintain validation documentation in an organized, retrievable manner.
• Support internal and external audits by providing validation documentation and SME input.

Skills

Risk assessment

Validation execution

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering or related scientific discipline

Tools

IQ/OQ/PQ protocols

Job description

The Pivot Group Network partners with West Michigan manufacturers to connect qualified Validation Engineers with ongoing and upcoming opportunities in Coopersville, MI. This role emphasizes the design, execution, and documentation of IQ, OQ, and PQ validation programs across equipment, processes, and software.

You will assess risks, generate validation plans, and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP while coordinating with R&D, Quality, and Manufacturing teams to drive