Soltech Pr

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.

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.

Job Details

Contract Duration: 6 months +

Pay Range: $65-$75 per hour

Location: On Site (New Albany, Ohio)

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!