C&Q Engineer, Sr.

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

About Ultimate Solutions Corp.

Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For over 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to global leaders in the pharmaceutical, biotechnology, medical device, and logistics sectors.

Key Responsibilities

• Plan, coordinate, and execute commissioning and qualification (C&Q) activities for Packaging Equipment.
• Develop and review C&Q documentation, including protocols, test scripts, reports, and traceability matrices.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
• Ensure equipment and systems meet design specifications, user requirements, and applicable 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.

Required 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.
• Strong and proven knowledge of the complete equipment validation life cycle, including URS, FAT/SAT, IQ, OQ, and PQ documentation and execution.
• Experience with Packaging Equipment is strictly required - particularly Dividella Cartoner and ATS Assembly Systems.
• Deep understanding of GMP regulations, ISPE Baseline Guides, and ASTM E2500 principles.
• Ability to read and interpret P&IDs, electrical schematics, and system design documents.
• Experience with automation systems, process equipment, and utilities in pharmaceutical or biotechnology manufacturing.
• Excellent technical writing, analytical, and organizational skills.
• Strong communication and teamwork abilities.

Additional Requirements

• Ability to multi-task and work under pressure.
• Capable of understanding complex problems, collaborating across disciplines, and developing effective solutions.
• Ability to negotiate and integrate different viewpoints in highly complex situations.
• Proficiency in composing technical documents, outlines, and concise reports, as well as communicating technical information effectively.

Not open for Corp-to-Corp arrangements

Ultimate Solutions USA, LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.