C&Q Specialist | Pharmaceutical

Job Description

Job Description

LOCATION: Barceloneta / Manatí, Puerto Rico

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.

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.

• 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.

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.

• 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 or other related fields.

Experience Requirements:

• 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.

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