C&Q Engineer

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has deliver proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

Summary:

The Commissioning & Qualification Engineer 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. This role involves planning, executing, and documenting C&Q activities to ensure systems are ready for production use.

Key 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.

Required Qualifications:

• Bachelors degree in Engineering, Life Sciences, or related field.

• 3+ 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.

Preferred Experience:

• 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.

Additional Requirements:

• Ability to work on-site and travel as required for project needs.

• Must adhere to all site safety policies and requirements.