Grand Rapids Validation Engineer — Manufacturing Focus

the-pivot-group-careers; Grand Rapids (MI); On-site; USD 81,000 - 121,000; Full time

Job summary

The Pivot Group Network is collaborating with Grand Rapids manufacturing firms to identify a skilled Validation Engineer. The role centers on creating and executing validation protocols for equipment, processes, and software in regulated manufacturing environments.

Candidates should hold a Bachelor's degree in Engineering or Life Sciences and have 2+ years of validation experience with knowledge of GxP regulations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 2+ years of experience in validation within a regulated manufacturing environment (e.g., Pharma, Biotech, Medical Device).
• Demonstrated knowledge of GxP regulations (e.g., FDA 21 CFR Parts 210, 211, 820) and industry standards (ICH, ISO).
• Proficiency in developing, executing, and reviewing validation protocols and reports (IQ, OQ, PQ) for equipment, processes, and software.
• Experience with quality management systems and deviation investigation processes.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and software.
• Perform IQ, OQ, and PQ activities for new and modified manufacturing systems.
• Conduct risk assessments and develop validation strategies in accordance with regulatory requirements.
• Analyze validation data, prepare reports, and present findings to cross-functional teams.
• Investigate and resolve validation deviations and non-conformances.
• Maintain validation documentation and ensure compliance with internal procedures and external regulations.
• Support the continuous improvement of validation processes and methodologies.

Job description

The Pivot Group Network is collaborating with Grand Rapids manufacturing firms to identify a skilled Validation Engineer. The role centers on creating and executing validation protocols for equipment, processes, and software in regulated manufacturing environments.

Candidates should hold a Bachelor's degree in Engineering or Life Sciences and have 2+ years of validation experience with knowledge of GxP regulations.