C&Q Specialist — Biotech Validation & Qualification

FITS LLC; Juncos (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

FITS LLC is seeking a C&Q Specialist in Puerto Rico to own qualification activities end to end. You will develop and execute IQ, OQ, and PQ for process equipment, facilities, and utilities, delivering audit-ready reports.

A bachelor’s degree in science or engineering with 5+ years in commissioning is required, along with bilingual Spanish and English proficiency. The role involves reviewing P&IDs, drawings, calibration records, and vendor documents; addressing review comments; and coordinating

Qualifications

• Bachelor’s degree in a Science or Engineering field is required.
• 5+ years of experience in commissioning and qualification processes.

Responsibilities

• Develop IQ, OQ, and PQ protocols for process equipment, facilities, and utilities.
• Execute IQ, OQ, and PQ protocols according to schedule.
• Prepare audit-ready reports and complete qualification summaries with evidence and conclusions.
• Coordinate with System Owners, Engineering, Quality, and Manufacturing.
• Assemble execution packages including protocols, raw data, and final reports.

Skills

IQ/OQ/PQ execution

ALCOA+ documentation

Bilingual English/Spanish

Education

Bachelor’s degree in Science or Engineering

Tools

Kneat

CDOCS

TrackWise

Job description

FITS LLC is seeking a C&Q Specialist in Puerto Rico to own qualification activities end to end. You will develop and execute IQ, OQ, and PQ for process equipment, facilities, and utilities, delivering audit-ready reports.

A bachelor’s degree in science or engineering with 5+ years in commissioning is required, along with bilingual Spanish and English proficiency. The role involves reviewing P&IDs, drawings, calibration records, and vendor documents; addressing review comments; and coordinating