Lead Validation Engineer: IQ/OQ/PQ, GMP Compliance

the-pivot-group-careers; DeWitt (MI); On-site; USD 74,000 - 113,000; Full time

Job summary

The Pivot Group Network in DeWitt, MI is recruiting a Validation Engineer to lead validation activities for manufacturing equipment, systems, and processes. You will design, execute, and oversee IQ, OQ, and PQ protocols to ensure GMP compliance and product quality.

We are seeking candidates with 3+ years in validated environments (medical device/pharma) and strong technical writing. Salary ranges from $74,000 to $113,000 depending on experience, with opportunities for growth and impact.

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).
• Demonstrated knowledge of GxP regulations (e.g., FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Experience with IQ, OQ, PQ, software validation, and process validation.
• Strong technical writing skills for creating and reviewing validation protocols and reports.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment, systems, and processes.
• Perform risk assessments and generate validation plans in compliance with regulatory requirements.
• Analyze validation data, generate reports, and present findings to cross-functional teams.
• Investigate deviations, implement corrective actions, and manage change control processes related to validation.
• Collaborate with R&D, Quality, Manufacturing, and Engineering teams to ensure successful project execution and product launches.
• Maintain validation documentation and ensure audit readiness in accordance with GMP guidelines.
• Support continuous improvement initiatives for validation processes and procedures.

Skills

Regulatory knowledge

Technical writing

Cross-functional collaboration

Risk assessment

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ execution

Validation protocols

Job description

The Pivot Group Network in DeWitt, MI is recruiting a Validation Engineer to lead validation activities for manufacturing equipment, systems, and processes. You will design, execute, and oversee IQ, OQ, and PQ protocols to ensure GMP compliance and product quality.

We are seeking candidates with 3+ years in validated environments (medical device/pharma) and strong technical writing. Salary ranges from $74,000 to $113,000 depending on experience, with opportunities for growth and impact.