C&Q Specialist

For C&Q services in Business Operations. 

WHAT MAKES YOU A FIT: 

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
• Shift: Administrative, and according to business needs
• Bilingual (Spanish and English)

Preferred Qualifications:    

• 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

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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
• 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

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?

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