Location: Manatí, Puerto Rico - on-site
Employment type: Regular employeePosition SummaryWe are seeking a Commissioning & Qualification (C&Q) Specialist to support a pharmaceutical manufacturing facility in Manatí, Puerto Rico. Strong hands-on experience in C&Q of sterile manufacturing areas and proficiency with the ALM electronic validation system are essential for this role.
The specialist will support commissioning, qualification, validation, startup, and operational readiness activities for pharmaceutical equipment, utilities, facilities, computerized systems, and manufacturing areas.
Key Responsibilities- Develop, review, and execute commissioning and IQ/OQ/PQ protocols for sterile manufacturing areas, pharmaceutical equipment, utilities, facilities, and manufacturing systems.
- Support C&Q activities involving autoclaves, clean utilities, HVAC, Building Automation Systems (BAS), and other systems used in sterile manufacturing.
- Develop and execute electronic protocols and test scripts in ALM, maintaining accurate test evidence, traceability, deviations, and documentation.
- Support construction turnover, startup, qualification readiness, and operational readiness.
- Support Computerized System Validation (CSV) activities, including requirements, risk assessments, testing, and traceability.
- Prepare protocols, reports, test records, SOPs, and qualification packages in compliance with cGMP, FDA requirements, and company procedures.
- Support change controls, investigations, deviations, CAPA, system upgrades, requalification, and decommissioning.
- Collaborate with Quality, Validation, Engineering, Automation, Manufacturing, Facilities, Construction, CSV, and vendors.
Required Qualifications- Bachelor's degree in Engineering, Life Sciences, Computer Science, Information Technology, or a related field.
- At least 5 years of experience in pharmaceutical commissioning, qualification, validation, facilities/utilities, engineering support, or related projects.
- Strong, hands-on C&Q experience in sterile pharmaceutical manufacturing areas.
- Hands-on experience using ALM to develop or execute electronic validation protocols and test scripts and manage associated documentation.
- Experience developing, reviewing, and executing commissioning and IQ/OQ/PQ protocols.
- Experience with pharmaceutical systems such as autoclaves, clean utilities, HVAC, and BAS.
- Strong knowledge of cGMP and experience in FDA-regulated environments.
- Fluency in English and Spanish, spoken and written.
- Strong technical writing, communication, and problem-solving skills.
