Manufacturing Validation Engineer - Drive Quality & Compliance

the-pivot-group-careers; Battle Creek (MI); On-site; USD 77,000 - 117,000; Full time

Job summary

The Pivot Group Network in Battle Creek, MI is seeking a Validation Engineer to support manufacturing validation initiatives across QA and operations. This role focuses on ensuring compliance with GxP and delivering IQ/OQ/PQ protocols for equipment, processes, and software.

The ideal candidate brings 3+ years of validation experience in a manufacturing setting (pharma/biotech/medical devices preferred) and a solid ability to perform risk assessments and root-cause analyses to drive continuous

Qualifications

• Bachelor's degree in engineering or related science discipline.
• 3+ years of validation experience in a manufacturing environment (pharma/biotech/medical device preferred).
• Strong understanding of GxP regulations (e.g., CFR Part 210, 211, 820) and industry standards.
• Proven experience authoring and executing validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Demonstrated ability to perform risk assessments and root cause analysis.

Responsibilities

• Support operational excellence and continuous improvement initiatives.

Skills

Validation experience

GxP regulations

IQ/OQ/PQ protocols

Risk assessment

Root cause analysis

Education

Bachelor's degree in engineering or related scientific discipline

Tools

MiniTab

JMP

SCADA

DCS

PLC programming

Job description

The Pivot Group Network in Battle Creek, MI is seeking a Validation Engineer to support manufacturing validation initiatives across QA and operations. This role focuses on ensuring compliance with GxP and delivering IQ/OQ/PQ protocols for equipment, processes, and software.

The ideal candidate brings 3+ years of validation experience in a manufacturing setting (pharma/biotech/medical devices preferred) and a solid ability to perform risk assessments and root-cause analyses to drive continuous