C&Q Engineer, Jr.

Ultimate Solutions • Columbus, OH

1d

About The Position

The Commissioning & Qualification Engineer, Jr. is responsible for ensuring that new or modified equipment, systems, and facilities are installed, commissioned, and qualified in accordance with Good Manufacturing Practices (GMP) and regulatory requirements. The role plans, executes, and documents commissioning and qualification (C&Q) activities to ensure systems are ready for production use.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• At least 2 years of experience in commissioning, qualification, or validation within a GMP-regulated environment.
• Strong understanding of IQ/OQ/PQ processes, GMP regulations, and industry standards, including ISPE Baseline Guides and ASTM E2500.
• 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.
• Strong attention to detail and technical writing skills.
• Effective communication and teamwork skills.

Nice To Haves

• Experience with risk-based C&Q approaches.
• Familiarity with validation software tools for protocol development and execution.
• Project management experience in a schedule-driven environment.
• Knowledge of cleaning, process, and computer systems validation principles.

Responsibilities

• Plan, coordinate, and execute commissioning and qualification activities for equipment, utilities, automation systems, and facilities.
• 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.
• Work 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 corrective/preventive action (CAPA) activities.
• Maintain compliance with GMP, safety, and environmental requirements throughout project execution.
• Ensure C&Q documentation is complete, accurate, and audit-ready.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level