GMP-Driven Equipment Qualification Engineer

Experis; Swiftwater (Monroe County); On-site; USD 90,000 - 130,000; Full time

Job summary

Experis is seeking an Equipment Qualification Engineer in Swiftwater, PA to support GMP validation and CQV activities within QA and Engineering.

You will lead IQ/OQ/PQ execution, prepare protocols and reports, manage deviations and CAPA, and collaborate with production and utility teams to ensure equipment readiness.

This role offers exposure to remediation and requalification programs and a commitment to quality and continuous improvement.

Qualifications

• Experience in Equipment Requalification and GMP validation activities.
• Knowledge of IQ/OQ/PQ processes and validation protocols.
• Background in Engineering, Utilities & Facilities management.
• Strong understanding of Equipment Lifecycle Management; ability to manage deviations and CAPA.

Responsibilities

• Lead and execute equipment requalification activities to ensure GMP compliance.
• Prepare and review qualification protocols and reports to maintain documentation integrity.
• Perform IQ/OQ/PQ activities to validate equipment performance and functionality.
• Support CQV execution across production and utility systems.
• Manage deviations and CAPA linked to qualification activities to improve processes.

Skills

IQ/OQ/PQ processes

GMP validation

CAPA management

Equipment lifecycle management

Engineering background

Education

Engineering degree

Job description

Experis is seeking an Equipment Qualification Engineer in Swiftwater, PA to support GMP validation and CQV activities within QA and Engineering.

You will lead IQ/OQ/PQ execution, prepare protocols and reports, manage deviations and CAPA, and collaborate with production and utility teams to ensure equipment readiness.

This role offers exposure to remediation and requalification programs and a commitment to quality and continuous improvement.