Sr. C&Q Packaging Equipment Engineer - Ohio - Onsite

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Job Title: Sr. C&Q Packaging Equipment Engineer

Location: Ohio

Can do Only W2, No C2C

MOI: SKYPE

Job Description:

The Sr. C&Q Packaging Equipment Engineer will support the commissioning, qualification, and startup of pharmaceutical packaging equipment and systems for a 12-month assignment in Ohio. This role is critical to ensuring packaging lines are properly installed, tested, validated, and released for GMP production in compliance with regulatory and company standards. The engineer will collaborate cross-functionally with Manufacturing, Quality Assurance, Automation, Maintenance, vendors, and system integrators to efficiently bring new or upgraded packaging lines into operational readiness. Responsibilities include leading and executing commissioning and qualification activities, including IQ/OQ/PQ protocols, for packaging equipment such as labeling, cartoning, serialization, inspection, and case packing systems. The engineer will develop and review validation lifecycle documentation, including commissioning plans, qualification protocols, traceability matrices, and summary reports, while supporting Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities. Additional responsibilities include troubleshooting equipment issues during startup and qualification phases to minimize production delays, ensuring compliance with GMP, FDA, and global regulatory requirements, supporting risk assessments such as FMEA, and implementing mitigation strategies. The role will also involve reviewing and approving change controls, deviations, and CAPAs related to packaging equipment, as well as driving continuous improvement initiatives focused on enhancing packaging line efficiency, reliability, and compliance

Best Regards:

Julia T

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