Validation Engineer: IQ/OQ/PQ & Regulatory Validation

the-pivot-group-careers; Atlanta (MI); On-site; USD 77,000 - 117,000; Full time

Job summary

The Pivot Group Network is assisting West Michigan manufacturers in Whitehall to hire a Validation Engineer. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software, and support audits while ensuring regulatory compliance.

Ideal candidates bring 3+ years in regulated validation, a strong grasp of GxP and FDA/ISO standards, and a proven ability to analyze data and write conclusive validation reports.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3+ years experience in validation activities within a regulated manufacturing environment.
• Demonstrated understanding of GxP, FDA regulations, ISO 13485 and related standards.
• Proven experience in developing, executing, and reviewing validation protocols and reports.
• Strong analytical and problem-solving skills with the ability to interpret complex data.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans.
• Analyze data and write comprehensive validation reports summarizing results and conclusions.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Collaborate with cross-functional teams to ensure successful validation outcomes.
• Maintain validation documentation in accordance with regulatory requirements and internal procedures.
• Support internal and external audits by providing validation documentation and expertise.

Skills

GxP knowledge

Analytical thinking

Cross-functional collaboration

Regulatory interpretation

Education

Bachelor's degree in Engineering/Life Sciences or related

Tools

IQ/OQ/PQ protocols

CSV / validation documents

Job description

The Pivot Group Network is assisting West Michigan manufacturers in Whitehall to hire a Validation Engineer. You will develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software, and support audits while ensuring regulatory compliance.

Ideal candidates bring 3+ years in regulated validation, a strong grasp of GxP and FDA/ISO standards, and a proven ability to analyze data and write conclusive validation reports.