Junior C&Q Engineer for GMP Validation & Commissioning

Ultimate Solutions Corp; Columbus (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Ultimate Solutions Corp is seeking a Jr. Commissioning & Qualification Engineer to ensure that new or modified equipment, systems, and facilities are installed, commissioned, and qualified in GMP-compliant ways. You will plan, execute, and document C&Q activities to prep systems for production.

Collaborate with project managers, engineering, validation, quality, and manufacturing teams to meet timelines, review protocols, test scripts, and reports, and maintain audit-ready documentation.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 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 (ISPE Baseline Guides, 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.

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 closely 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.

Skills

IQ/OQ/PQ

GMP

Technical writing

P&ID interpretation

Communication

Teamwork

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Validation software tools

Job description

Ultimate Solutions Corp is seeking a Jr. Commissioning & Qualification Engineer to ensure that new or modified equipment, systems, and facilities are installed, commissioned, and qualified in GMP-compliant ways. You will plan, execute, and document C&Q activities to prep systems for production.

Collaborate with project managers, engineering, validation, quality, and manufacturing teams to meet timelines, review protocols, test scripts, and reports, and maintain audit-ready documentation.