Senior C&Q Engineer for Packaging Equipment (GMP)

Ultimate Solutions Corp; Columbus (OH); On-site; USD 110,000 - 160,000; Full time

Job summary

Ultimate Solutions Corp specializes in packaging industrial automation, serialization, and regulatory compliance for life sciences. This position leads commissioning and qualification activities for packaging equipment, ensuring GMP compliance and audit readiness.

Responsibilities include developing C&Q docs, IQ/OQ/PQ testing, cross-functional collaboration, and CAPA support. Strong writing and teamwork are essential in a fast-paced, regulated environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 6+ years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
• Experience with Packaging Equipment is strictly required - Dividella Cartoner and ATS Assembly Systems.

Responsibilities

• Plan, coordinate, and execute commissioning and qualification activities for Packaging Equipment.
• Develop and review C&Q documentation, including protocols, test scripts, reports, and traceability matrices.
• Perform IQ, OQ, and PQ testing.
• Ensure equipment and systems meet design specifications and regulatory standards.
• Collaborate with project managers, engineering, validation, automation, quality, and manufacturing teams to align on project timelines and deliverables.
• Troubleshoot and resolve issues identified during C&Q execution.
• Support change control, deviation investigations, and CAPA activities.
• Maintain compliance with GMP, safety, and environmental requirements throughout project execution.
• Ensure all C&Q documentation is complete, accurate, and audit-ready.

Skills

Commissioning & Qualification

Validation lifecycle

GMP experience

Packaging equipment knowledge

GMP regulations

P&ID interpretation

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Dividella Cartoner

ATS Assembly Systems

Job description

Ultimate Solutions Corp specializes in packaging industrial automation, serialization, and regulatory compliance for life sciences. This position leads commissioning and qualification activities for packaging equipment, ensuring GMP compliance and audit readiness.

Responsibilities include developing C&Q docs, IQ/OQ/PQ testing, cross-functional collaboration, and CAPA support. Strong writing and teamwork are essential in a fast-paced, regulated environment.