Manufacturing Validation Engineer | IQ/OQ/PQ Expert

the-pivot-group-careers; Walker (MI); On-site; USD 81,000 - 121,000; Full time

Job summary

The Pivot Group Network is partnering with Walker, MI-based manufacturers to identify a Validation Engineer. Salary ranges from $81,000 to $121,000 depending on experience, with comprehensive benefits and growth opportunities.

As a Validation Engineer, you will develop and execute IQ/OQ/PQ protocols for equipment and processes, perform risk assessments, generate validation plans and reports, and collaborate with R&D, Quality, and Manufacturing to drive compliant solutions.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of validation experience in a regulated manufacturing environment.
• Strong understanding of GxP regulations and industry standards (FDA 21 CFR Part 820, ISO 13485).
• Experience developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Excellent technical writing and communication skills for validation documentation.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment and processes.
• Perform risk assessments and generate validation plans for new and modified systems.
• Analyze data and generate validation reports summarizing results and conclusions.
• Investigate deviations and non-conformances during validation activities, implementing corrective actions.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to ensure successful project execution.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Provide technical expertise and guidance on validation principles and best practices.

Skills

GxP regulations

Technical writing

Cross-functional collaboration

IQ/OQ/PQ protocol development

Education

Bachelor's degree in engineering or related scientific discipline

Tools

CSV experience

Job description

The Pivot Group Network is partnering with Walker, MI-based manufacturers to identify a Validation Engineer. Salary ranges from $81,000 to $121,000 depending on experience, with comprehensive benefits and growth opportunities.

As a Validation Engineer, you will develop and execute IQ/OQ/PQ protocols for equipment and processes, perform risk assessments, generate validation plans and reports, and collaborate with R&D, Quality, and Manufacturing to drive compliant solutions.