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 +
Pay Range: $65-$75 per hour
Location: On Site (New Albany, Ohio)
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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!