Validation Engineer — IQ/OQ/PQ Specialist

the-pivot-group-careers; Traverse City (MI); On-site; USD 73,000 - 112,000; Full time

Job summary

The Pivot Group Network in Traverse City, MI is seeking a Validation Engineer to develop and execute validation protocols for equipment, processes, and software, ensuring IQ, OQ, and PQ activities are thorough and well documented.

You will collaborate with cross-functional teams to perform risk assessments, analyze data with statistical tools, and maintain validation documentation across the system lifecycle. A Bachelor's degree and 3+ years in a regulated manufacturing environment are required.

Qualifications

• Bachelor's degree in engineering or a related scientific discipline is required.
• 3+ years of validation experience in a regulated manufacturing environment (e.g., medical devices, pharmaceuticals).
• Experience authoring and executing IQ/OQ/PQ protocols for equipment, processes, and software.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, PQ activities and generate validation reports.
• Conduct risk assessments and develop validation strategies in compliance with regulatory requirements.
• Collaborate with cross-functional teams to ensure successful implementation of validated systems.
• Investigate deviations and CAPA for non-conformities and update validation documentation.
• Maintain and update validation documentation throughout the system lifecycle.

Skills

IQ/OQ/PQ

Risk assessment

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

R

Python

Job description

The Pivot Group Network in Traverse City, MI is seeking a Validation Engineer to develop and execute validation protocols for equipment, processes, and software, ensuring IQ, OQ, and PQ activities are thorough and well documented.

You will collaborate with cross-functional teams to perform risk assessments, analyze data with statistical tools, and maintain validation documentation across the system lifecycle. A Bachelor's degree and 3+ years in a regulated manufacturing environment are required.