We are seeking a Commissioning & Qualification (C&Q) Specialist to support pharmaceutical manufacturing facilities located in the North Area of Puerto Rico (Barceloneta / Manatí). The specialist will be responsible for supporting commissioning, qualification, validation, and implementation activities for pharmaceutical equipment, utilities, systems, and manufacturing areas while ensuring compliance with regulatory requirements and company standards.
This is a contract-based opportunity for an independent professional willing to work at client site.
Develop and execute qualification protocols including Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for pharmaceutical equipment, utilities, facilities, and manufacturing systems.
Ensure qualification and validation activities are performed in compliance with company procedures and regulatory requirements.
Manage Change Controls by initiating, reviewing, supporting execution activities, tracking associated tasks, and ensuring closure in accordance with FDA regulations, cGMP requirements, and company quality systems.
Execute installation and operational verification activities for pharmaceutical equipment and systems.
Support commissioning and startup activities across manufacturing and facility environments.
Identify and resolve technical issues encountered during qualification and validation execution.
Develop and maintain protocols, reports, test documentation, SOPs, and qualification packages ensuring complete traceability.
Ensure compliance with applicable global regulatory requirements (FDA, cGMP, ICH, and internal quality standards).
Support periodic reviews, requalification activities, and lifecycle management of systems and equipment.
Coordinate system modifications, upgrades, decommissioning activities, and troubleshooting efforts.
Collaborate with Quality, Validation, Manufacturing, Engineering, Automation, and cross-functional teams to ensure successful project execution.
Minimum of 3 years of experience in Commissioning & Qualification (C&Q), Validation, Engineering Support, Manufacturing Support, or related pharmaceutical functions.
Experience working in pharmaceutical manufacturing environments under cGMP and FDA regulations.
Strong understanding of equipment qualification, facility qualification, validation lifecycle activities, and risk assessment principles.
Experience supporting investigations, deviations, CAPA, and change control processes.
Experience in qualification of equipment, utilities, facilities, cleanrooms, or manufacturing systems is preferred.
Prior experience supporting sterile manufacturing or injectable pharmaceutical operations is highly preferred.
Experience supporting project execution and cross-functional implementation activities is preferred.
