Validation Engineer: IQ/OQ/PQ for Regulated Manufacturing

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

Job summary

The Pivot Group Network is actively seeking a Validation Engineer in Zeeland, MI to develop and execute comprehensive IQ, OQ, and PQ validation protocols for equipment, processes, and software. You will perform risk assessments, analyze data, and generate clear validation reports to support regulatory compliance.

Collaborating with R&D, Quality, and Manufacturing, you will maintain documentation in an auditable format and assist in audits.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline.
• 3+ years of validation experience in regulated manufacturing (medical device, pharma).
• Strong knowledge of GxP regulations (FDA 21 CFR Part 820, Part 210/211, ISO 13485).
• Proven experience developing and executing IQ, OQ, PQ validation protocols.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Perform risk assessments and generate validation plans to ensure regulatory compliance.
• Analyze data and generate comprehensive validation reports summarizing test results and conclusions.
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define validation strategies.
• Investigate and resolve deviations or non-conformances identified during validation activities.
• Maintain validation documentation in an organized and auditable manner.
• Support internal and external audits by providing validation documentation and expertise.

Skills

IQ/OQ/PQ

Risk assessment

Root cause analysis

Data analysis

Education

Bachelor's degree in engineering or related science

Job description

The Pivot Group Network is actively seeking a Validation Engineer in Zeeland, MI to develop and execute comprehensive IQ, OQ, and PQ validation protocols for equipment, processes, and software. You will perform risk assessments, analyze data, and generate clear validation reports to support regulatory compliance.

Collaborating with R&D, Quality, and Manufacturing, you will maintain documentation in an auditable format and assist in audits.