C&Q Specialist

F or C&Q services in Business Operations.

About Flexible & Integrated Technical Services, LLC

• Being a FITS Piece Comes With Perks Work on high-impact projects with one of Puerto Rico’s top biotechnology manufacturers
• Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices
• Who We Are FITS is a Puerto Rico-based engineering and technical firm.
• We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing.
• We believe the right talent fits like the right piece, and we work to make every placement a match that lasts.
• Are you the Next Piece?

Responsibilities

• FITS is looking for a C&Q Specialist to support a leading biotechnology manufacturer.
• You’ll own qualification activities end to end: developing protocols, executing IQ, OQ, and PQ for process equipment, facilities, and utilities, and delivering complete, audit-ready reports.
• If you enjoy hands-on testing and take pride in documentation that holds up to any review, this role is for you.
• Bachelor’s degree in a Science or Engineering field, with 5+ years of experience in commissioning and qualification processes, including protocol generation and execution

Administrative, and according to business needs

• Experience with commissioning, qualification, and validation in a regulated biopharmaceutical or pharmaceutical manufacturing environment
• Experience with electronic document, training, and project systems such as Kneat, CDOCS, and TrackWise AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
• 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/interlock challenges, operating-range testing, and functional and performance testing, along with other approved protocol activities for the assigned system 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 that clearly summarize 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

Preferred

• Experience independently developing, executing, and reporting IQ, OQ, and PQ activities for process equipment, facilities, or utilities
• Develop IQ, OQ, and PQ protocols that cover 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