C&Q Engineer, Sr.

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

• 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.

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ 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.

• Must possess the ability to multi-task
• Must possess the ability to work under pressure.
• Ability to understand complex problems and to collaborate and explore alternative solutions.
• Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
• Ability to compose letters, outlines, and basic reports and/or to orally communicate technical information.

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.