Commissioning & Qualification Specialist (C&Q)

About the role

The company is seeking a Commissioning & Qualification (C&Q) Specialist to support a pharmaceutical manufacturing facility in Manatí, Puerto Rico. The role involves hands‑on work in sterile manufacturing areas and the use of the ALM electronic validation system.

Key responsibilities

• Develop, review and execute commissioning and IQ/OQ/PQ protocols for sterile manufacturing equipment, utilities, facilities and computerized systems.
• Support C&Q activities for autoclaves, clean utilities, HVAC, Building Automation Systems and other sterile manufacturing systems.
• Create and manage electronic protocols and test scripts in ALM, ensuring traceability, deviations and documentation are maintained.
• Assist with construction turnover, startup, qualification readiness and operational readiness.
• Participate in Computerized System Validation (CSV) tasks, including requirements definition, risk assessments, testing and traceability.
• Prepare protocols, reports, SOPs and qualification packages in compliance with cGMP, FDA regulations and company procedures.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information Technology or a related field.
• Minimum 5 years of experience in pharmaceutical commissioning, qualification, validation or related projects.
• Strong hands‑on C&Q experience in sterile pharmaceutical manufacturing areas.
• Fluency in English and Spanish, both spoken and written.

Required skills

• ALM electronic validation system.
• IQ/OQ/PQ protocol development and execution.
• Experience with autoclaves, clean utilities, HVAC and Building Automation Systems.
• Computerized System Validation (CSV) processes.
• Knowledge of cGMP and FDA‑regulated environments.