C&Q Specialist | Pharmaceutical | Manati, PR

About the role

Legal PM Partners (LPMP) is seeking a Commissioning & Qualification (C&Q) Specialist to support pharmaceutical manufacturing facilities in the North Area of Puerto Rico (Barceloneta / Manatí). This contract-based opportunity is for an independent professional. The role supports commissioning, qualification, validation, CSV, and implementation activities for pharmaceutical equipment, utilities, computerized systems, and manufacturing areas while ensuring compliance with regulatory requirements and company standards.

The ideal candidate has hands-on C&Q experience, including protocol development and execution, equipment and system qualification, and exposure to Computerized System Validation (CSV), electronic protocols, and electronic lifecycle management systems such as ALM.

Responsibilities

• Develop and execute commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for pharmaceutical equipment, utilities, facilities, and manufacturing systems.
• Develop, review, and execute electronic qualification protocols and test scripts using applicable electronic validation or lifecycle management systems.
• Support the execution and documentation of Computerized System Validation (CSV) activities for computerized, automated, and manufacturing systems.
• Support CSV lifecycle activities, including requirements, risk assessments, test execution, deviation/discrepancy management, traceability, and validation documentation.
• Use and maintain electronic lifecycle management / ALM systems, when applicable, for protocol execution, test management, requirements traceability, documentation, and validation records.
• Ensure qualification and validation activities are performed in compliance with company procedures and regulatory requirements.

Requirements

• Hands-on C&Q experience, including protocol development and execution and equipment and system qualification.
• Exposure to CSV, electronic protocols, and electronic lifecycle management systems such as ALM.

Datos clave

• Contract-based opportunity for an independent professional.
• Supports pharmaceutical manufacturing facilities in the North Area of Puerto Rico (Barceloneta / Manatí).
• The role includes commissioning, qualification, validation, CSV, and implementation activities.
• The ideal candidate has hands-on C&Q experience and exposure to CSV, electronic protocols, and ALM systems.