CQ Specialist Pharmaceutical Manati PR

Location: Manatí, PR | On SiteIndustry: Pharmaceutical ManufacturingPosition Type: Contract
Job DescriptionWe 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, 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 will have strong hands-on C&Q experience, including protocol development and execution, equipment and system qualification, as well as exposure to Computerized System Validation (CSV), electronic protocols, and electronic lifecycle management systems such as ALM.This is a contract-based opportunity for an independent professional willing to work at the client site.
Main Responsibilities 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.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.Utilize 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.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.Review and document electronic test results, discrepancies, deviations, and exceptions generated during qualification and validation activities.Ensure compliance with applicable global regulatory requirements, including 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, CSV, and cross-functional teams to ensure successful project execution.Support the implementation and integration of new equipment, automated systems, and computerized systems within pharmaceutical manufacturing environments.
General Requirements Fluent in Spanish and English (spoken and written).Proficiency in Microsoft Office 365 (Teams, SharePoint, Outlook, Excel, Word, PowerPoint).Strong documentation and technical writing skills.Strong understanding of electronic documentation and protocol execution.Experience working with electronic validation, test execution, or lifecycle management platforms is highly preferred.Experience with ALM or similar electronic lifecycle management systems is preferred.Excellent attention to detail and quality mindset.Effective communication skills and ability to interact with cross-functional teams.Strong analytical and problem-solving capabilities.Ability to manage multiple priorities and work in fast-paced environments.
Education Requirements Bachelor’s Degree in Engineering, Life Sciences, Computer Science, Information Technology, or another related field.
Experience Requirements Minimum of 3 years of experience in Commissioning & Qualification (C&Q), Validation, Engineering Support, Manufacturing Support, CSV, or related pharmaceutical functions.Experience working in pharmaceutical manufacturing environments under cGMP and FDA regulations.Strong understanding of equipment qualification, facility qualification, computerized system validation, validation lifecycle activities, and risk assessment principles.Hands-on experience developing, reviewing, and/or executing IQ/OQ/PQ and commissioning protocols.Experience with electronic protocols and electronic test execution is highly preferred.Experience with Computerized System Validation (CSV) activities is highly preferred.Experience using ALM or similar electronic lifecycle management / validation systems is preferred.Experience supporting investigations, deviations, CAPA, and change control processes.Experience in qualification of equipment, utilities, facilities, cleanrooms, computerized systems, 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.Experience with automation, control systems, manufacturing systems, or computerized equipment is a plus.
Physical Requirements Ability to sit for extended periods.Light physical activity may be required occasionally.Must be able to visit field locations as needed.Must be able to wear personal protective equipment (PPE) when required.Ability to work in a variety of industrial and manufacturing environments.Ability to work on-site in pharmaceutical manufacturing facilities in the North Area of Puerto Rico.