Validation Engineer — IQ/OQ/PQ Specialist

the-pivot-group-careers

Traverse City (MI)

On-site

USD 73,000 - 112,000

Full time

3 days ago
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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.

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