Validation Engineer | IQ/OQ/PQ, ISO-FDA Compliance

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

Job summary

The Pivot Group Network in Fremont, MI is actively seeking a Validation Engineer to develop and execute IQ/OQ/PQ validation for manufacturing equipment and processes. The role requires collaboration with engineering, quality, and production teams and a focus on regulatory compliance (FDA, ISO).

Salary ranges from $79,000 to $119,000 depending on experience, with opportunities for growth in a manufacturing-focused network serving West Michigan and beyond.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of validation experience in a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations and industry standards (FDA 21 CFR Part 820, ISO 13485).
• Proven experience with validation methodologies including IQ, OQ, PQ for equipment, processes, and software.
• Excellent technical writing skills for creating and reviewing validation protocols and reports.

Responsibilities

• Develop and execute validation protocols (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).
• Analyze validation data, write reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and ensure proper documentation of all validation activities.
• Maintain and update validation master plans, procedures, and related documentation.
• Collaborate with engineering, quality, and production teams to support new product introductions and process improvements.
• Conduct periodic reviews of validated systems to ensure continued compliance and effectiveness.

Skills

IQ/OQ/PQ validation

GxP compliance

Technical writing

Education

Bachelor's degree in engineering or related field

Job description

The Pivot Group Network in Fremont, MI is actively seeking a Validation Engineer to develop and execute IQ/OQ/PQ validation for manufacturing equipment and processes. The role requires collaboration with engineering, quality, and production teams and a focus on regulatory compliance (FDA, ISO).

Salary ranges from $79,000 to $119,000 depending on experience, with opportunities for growth in a manufacturing-focused network serving West Michigan and beyond.