C&Q Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

2d

About The Position

FITS is seeking a C&Q Specialist to support a leading biotechnology manufacturer in Business Operations. The specialist owns commissioning and qualification activities end to end, including developing protocols, executing IQ, OQ, and PQ for process equipment, facilities, and utilities, and delivering complete, audit-ready reports. The role involves hands-on testing, coordination with cross-functional site teams, and maintaining thorough documentation that meets review requirements. The shift is administrative and may vary according to business needs.

Requirements

• Bachelor’s degree in a Science or Engineering field.
• At least 5 years of experience in commissioning and qualification processes, including protocol generation and execution.
• Bilingual in Spanish and English.

Nice To Haves

• Experience with commissioning, qualification, and validation in a regulated biopharmaceutical or pharmaceutical manufacturing environment.
• Experience independently developing, executing, and reporting IQ, OQ, and PQ activities for process equipment, facilities, or utilities.
• Experience with electronic document, training, and project systems such as Kneat, CDOCS, and TrackWise.

Responsibilities

• Develop IQ, OQ, and PQ protocols covering prerequisite verification, instrument and calibration status, materials, test equipment, safety controls, data recording requirements, and discrepancy handling.
• Interpret P&IDs, equipment drawings, specifications, control narratives, vendor documents, calibration records, and applicable automation documentation.
• Address review-cycle comments and revise documents through approval and readiness for execution.
• Execute approved IQ, OQ, and PQ protocols for process equipment, facilities, and utilities according to the authorized schedule.
• Perform installation verification, component and instrument checks, drawing and configuration verification, alarm and interlock challenges, operating-range testing, and functional and performance testing.
• Collect objective evidence, including test data and approved attachments, that meets ALCOA+ principles.
• Coordinate execution with System Owners, Engineering, Automation, Quality, Manufacturing, Maintenance, EHS, vendors, and other project personnel.
• Document protocol discrepancies and deviations according to site procedures.
• Provide technical input on impact assessments, troubleshooting, root cause evaluation, retesting strategy, corrective actions, and closure documentation.
• Prepare IQ, OQ, and PQ reports or combined qualification summary reports summarizing scope, execution results, discrepancies, resolutions, outstanding items, and conclusions.
• Assemble complete and accurate execution packages, including approved protocols, raw data, attachments, supporting evidence, discrepancy records, and final reports.
• Address review comments and close documentation within the agreed schedule.

Benefits

• Opportunities to work on high-impact projects with one of Puerto Rico’s top biotechnology manufacturers.
• Opportunities to grow a career across FITS’ network of clients in pharma, biotech, and medical devices.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level