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

Soltech PR; Puerto Rico; 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

Summary:

Commissioning & Qualification Engineer with experience in GMP-regulated pharmaceutical or biotechnology environments, responsible for leading commissioning, qualification, and validation activities for packaging equipment. Expertise in executing IQ/OQ/PQ protocols, developing qualification documentation, supporting regulatory compliance, and collaborating with cross-functional teams. Experience with Dividella Cartoners, ATS Assembly Systems, validation lifecycle activities (URS, FAT/SAT, IQ, OQ, PQ), and GMP/ISPE/ASTM standards is required.

Scope of Work / Key Responsibilities:

• Plan and execute commissioning and qualification (C&Q) 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 compliance with user requirements, design specifications, and regulatory standards.
• 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.

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Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3+ years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
• Strong knowledge of equipment validation lifecycle activities, including URS, FAT/SAT, IQ, OQ, and PQ.
• Required 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 or biotechnology manufacturing processes.

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Job Details:

Contract Duration: 6 months +

Location: On Site (East, Puerto Rico)

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Why Apply?

This is a unique opportunity to work on a high-impact project in the pharmaceutical sector with a respected and growing firm. At SoltechPR, we value our people and are committed to offering meaningful work, professional development, and a supportive team environment. If you’re ready to bring your expertise to a major construction initiative in the regulated industry, we’d love to hear from you.

Apply today and become part of something impactful!