Senior Validation Engineer: GMP-Driven Manufacturing

the-pivot-group-careers; Lansing (MI); On-site; USD 78,000 - 118,000; Full time

Job summary

The Pivot Group Network in Lansing, MI is seeking an experienced Validation Engineer to partner with leading manufacturing companies. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software, ensuring compliance with FDA, ISO, and industry standards.

You will perform risk assessments, maintain validation documentation, and support audits while collaborating with R&D, Quality, and Manufacturing to drive compliant results.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• 3+ years of experience in validation activities within a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Strong understanding of GxP regulations (FDA 21 CFR Part 820, ISO 13485) and industry validation standards.
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Familiarity with statistical methods for data analysis and process capability studies.

Responsibilities

• Develop, execute, and review validation protocols and reports (IQ, OQ, PQ) for manufacturing equipment, processes, and systems.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Collaborate with cross-functional teams to define validation strategies and acceptance criteria.
• Investigate and resolve deviations and non-conformances encountered during validation activities.
• Maintain and update validation documentation, including procedures, master plans, and summaries.
• Provide technical expertise and guidance on validation principles and regulatory expectations to project teams.
• Support internal and external audits by providing validation documentation and responding to inquiries.

Skills

Validation

GxP knowledge

IQ/OQ/PQ

Statistical methods

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

CSV validation

Statistical analysis tools

Job description

The Pivot Group Network in Lansing, MI is seeking an experienced Validation Engineer to partner with leading manufacturing companies. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software, ensuring compliance with FDA, ISO, and industry standards.

You will perform risk assessments, maintain validation documentation, and support audits while collaborating with R&D, Quality, and Manufacturing to drive compliant results.