GxP Validation Engineer for Manufacturing

the-pivot-group-careers

Paw Paw (MI)

On-site

USD 80,000 - 120,000

Full time

3 days ago

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Job summary

The Pivot Group Network in West Michigan is seeking a Validation Engineer to support Paw Paw, MI area manufacturers. You will design and execute validation protocols for equipment, processes and software, and lead IQ/OQ/PQ activities within a regulated manufacturing setting.

Ideal candidates hold a Bachelor's in Engineering or Life Sciences with 3+ years of validation experience and solid knowledge of GxP, FDA 21 CFR Part 11, Part 820, ISO 13485, plus strong data analysis and risk assessment

Qualifications

Bachelor's degree in Engineering, Life Sciences, or related field.
3+ years of validation experience in a regulated manufacturing environment.
Experience with GxP regulations, FDA 21 CFR Part 11, Part 820, ISO 13485.

Responsibilities

Develop and execute validation protocols for equipment, processes, and software.
Perform IQ, OQ, and PQ activities for new and modified systems.
Analyze data and generate comprehensive validation reports.
Conduct risk assessments and develop mitigation strategies for manufacturing processes.
Ensure compliance with cGMP, FDA regulations, and industry standards.
Troubleshoot validation discrepancies and implement corrective actions.
Collaborate with cross-functional teams on product introductions and process improvements.