GMP Packaging C&Q Engineer (IQ/OQ/PQ)

Soltech PR; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Soltech PR is seeking a Commissioning & Qualification Engineer to lead C&Q activities for packaging equipment in a GMP-regulated environment. The role requires hands-on IQ/OQ/PQ testing, development of qualification documentation, and collaboration with cross-functional teams.

Responsibilities include executing validation activities, supporting change controls and CAPAs, and ensuring adherence to GMP, safety, and environmental standards on-site in Puerto Rico.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
• Strong knowledge of equipment validation lifecycle activities (URS, FAT/SAT, IQ, OQ, PQ).
• Experience with packaging equipment, specifically Dividella Cartoners and ATS Assembly Systems.
• Understanding of GMP regulations, ISPE Baseline Guides, and ASTM E2500.
• Ability to interpret P&IDs, electrical schematics, and engineering documentation.
• Experience with automation systems and pharmaceutical/biotechnology manufacturing processes.

Responsibilities

• Plan and execute commissioning and qualification activities for packaging equipment.
• Develop and review qualification documentation, including protocols, test scripts, reports, and traceability matrices.
• Perform IQ, OQ, and PQ testing to ensure regulatory compliance.
• Collaborate with cross-functional teams to meet project objectives and timelines.
• Support troubleshooting, change controls, deviations, CAPAs, and documentation readiness.
• Maintain compliance with GMP, safety, and environmental requirements.

Skills

QA/QC

GMP knowledge

IQ/OQ/PQ

Dividella Cartoners

ATS Assembly Systems

Regulatory compliance

P&ID interpretation

Automation in pharma

Education

Bachelor’s degree in Engineering

Job description

Soltech PR is seeking a Commissioning & Qualification Engineer to lead C&Q activities for packaging equipment in a GMP-regulated environment. The role requires hands-on IQ/OQ/PQ testing, development of qualification documentation, and collaboration with cross-functional teams.

Responsibilities include executing validation activities, supporting change controls and CAPAs, and ensuring adherence to GMP, safety, and environmental standards on-site in Puerto Rico.