Packaging Engineer

We are supporting a long-term onsite opportunity with a leading biopharma manufacturing team in Columbus, Ohio for a Sr. C&Q Packaging Equipment Engineer. This role will support the commissioning, qualification, and startup of new automated assembly, labeling, and packaging lines currently in the FAT phase, with installation and qualification activities scheduled next.

The team is seeking a hands-on engineer with strong equipment qualification experience, particularly in executing IQ/OQ/PQ activities within GMP-regulated manufacturing environments. While packaging equipment experience is preferred, the hiring manager is primarily focused on candidates who can independently drive commissioning and qualification activities, support startup operations, troubleshoot equipment issues, and complete documentation in a compliant and timely manner.

Key Responsibilities:

Support commissioning, startup, and qualification activities for automated packaging and assembly equipment

Develop and execute IQ/OQ/PQ protocols and validation documentation

Perform FAT/SAT support, equipment shakedown, and startup troubleshooting

Manage deviations, change controls, CAPAs, traceability matrices, and summary reports

Collaborate cross-functionally with Manufacturing, QA, Automation, Maintenance, vendors, and system integrators

Ensure compliance with GMP, FDA, and internal quality standards

Required Qualifications:

3+ years of C&Q, validation, or equipment qualification experience in pharma, biotech, medical device, or GMP manufacturing environments

Strong experience executing IQ/OQ/PQ protocols for manufacturing or packaging equipment

Hands-on experience with automated equipment such as packaging lines, labeling systems, cartoners, serialization equipment, inspection systems, case packers, or assembly equipment

Experience with FAT/SAT, commissioning, startup support, and equipment troubleshooting

Strong understanding of GMP documentation practices and regulated environments

Excellent communication and cross-functional coordination skills

Preferred Experience:

Biopharma or pharmaceutical packaging operations

Automated packaging or serialization systems

Experience supporting large-scale equipment installation or production line startup projects