Commissioning & Qualification Specialist

LOCATION: Las Piedras / Gurabo / Juncos

We are seeking a Commissioning & Qualification Specialist to support a pharmaceutical manufacturing facility in the central/East area of Puerto Rico. The specialist will be responsible for conducting qualification activities of equipment, utilities, and facilities to ensure they comply with installation and operations requirements and regulatory standards. This is a contract-based opportunity for an independent professional willing to work at client site.

Main Responsibilities:

• Develop and execute qualification protocols (Commissioning, IQ, OQ, PQ) for pharmaceutical equipment and facilities.
• Ensure qualification and validation activities meet company procedures and regulatory requirements.
• Manage Change Controls by initiating or reviewing for approval prior to execution, tracking associated tasks to ensure timely completion, and documenting closure in full compliance with FDA regulations, cGMP requirements, and company quality system procedures.
• Perform installation and operational checks for pharmaceutical equipment and systems.
• Develop commissioning protocols and execute commissioning activities for new or upgraded systems.
• Identify and resolve technical issues during qualification activities.
• Create and maintain accurate and complete documentation, including protocols, test scripts, reports, and SOPs. Ensure traceability of all qualification and validation activities.
• Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines.
• Support the periodic review and requalification of pharmaceutical systems.
• Coordinate system upgrades, decommissioning, and troubleshooting.
• Partner with QC, validation, IT, and engineering teams to ensure seamless implementation.
• Provide support during regulatory audits and inspections.

General Requirements:

• Fluent in Spanish and English (spoken and written).
• Proficiency in Microsoft Office 365 (Teams, SharePoint, Outlook, Excel, Word, PowerPoint) and project management tools.
• Proficiency in documentation practices and attention to detail.
• Effective communication skills and ability to present complex technical information to diverse audiences.
• Excellent problem-solving skills and ability to work collaboratively in a cross-functional team environment.
• Excellent communication skills.

Education Requirements:

• Bachelor’s Degree in engineering, life sciences or other related fields.

Experience Requirements:

• 3+ years qualifying facilities and equipment in the Pharmaceutical Industry.
• In-depth knowledge of regulatory requirements (e.g., cGMP, FDA) related to commissioning, qualification, and validation activities.
• Strong understanding of equipment and facility qualification, risk assessments, and validation principles.
• Experience in conducting investigations, particularly related to deviations, and familiarity with Corrective and Preventive Action (CAPA) processes.

Physical Requirements:

• Ability to sit for long periods.
• Light physical activity may be required occasionally.
• Must be able to visit field locations as needed.
• Must be able to use personal protective equipment (PPE) when required.
• Ability to perform in a variety of industrial environments.