Validation Engineer: Drive GxP IQ/OQ/PQ Excellence

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

Job summary

The Pivot Group Network in Hudsonville, MI is actively seeking a Validation Engineer to support validation activities for equipment, processes, and software in a regulated manufacturing environment.

The role requires 3+ years’ experience and a strong grasp of GxP, FDA regulations, and ISO 13485, with proven ability to generate validation documentation and write precise technical reports.

Qualifications

• Bachelor's degree in engineering or related field.
• 3+ years in validation within regulated manufacturing (medical devices/pharma).
• Strong understanding of GxP, FDA regulations, ISO 13485.
• Proven experience developing and executing validation protocols for equipment, processes, software.
• Excellent technical writing and communication skills.

Responsibilities

• Support operational excellence and continuous improvement initiatives

Skills

GxP awareness

FDA regulations

Technical writing

Communication

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ

Validation docs

Job description

The Pivot Group Network in Hudsonville, MI is actively seeking a Validation Engineer to support validation activities for equipment, processes, and software in a regulated manufacturing environment.

The role requires 3+ years’ experience and a strong grasp of GxP, FDA regulations, and ISO 13485, with proven ability to generate validation documentation and write precise technical reports.