C&Q Engineer - Contract Worker (On Site)

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! #J-18808-Ljbffr Soltech PR