C&Q Validation Engineer — Pharma Compliance & Commissioning

FITS LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a qualified candidate to support commissioning, qualification, and validation activities for process equipment, facilities, and utilities. The role requires a science or engineering background and at least two years of relevant experience, with fluency in Spanish and English to coordinate across teams.

The position involves reviewing and executing IQ/OQ/PQ protocols, preparing reports, and assembling execution packages, while collaborating with diverse project

Qualifications

• Bachelor’s degree in science or engineering with at least 2 years of experience in commissioning and qualification.
• Bilingual: Spanish and English.
• Shift: Administrative, per business needs.
• Experience in commissioning/qualification/validation in regulated biopharma or pharma manufacturing.
• Ability to independently develop, execute, and report IQ/OQ/PQ activities.
• Ability to use AML-designated systems after training (KNEAT, CDOCS, Trackwise).

Responsibilities

• Incorporate verification of prerequisite, calibration status, materials, test equipment, safety controls, data recording, and discrepancy handling.
• Support review-cycle comments and revise documents for approval and readiness for execution.
• Interpret P&IDs, equipment drawings, specifications, control narratives, vendor docs, calibration records, and automation documentation.
• Execute approved IQ, OQ, PQ protocols for process equipment, facilities, and utilities per schedule.
• Perform installation verification, instrument checks, drawing verification, configuration verification, alarms/interlocks, testing, and reporting.
• Collect ALCOA+ objective evidence including test data and attachments.
• Coordinate execution with System Owners, Engineering, Automation, Quality, Manufacturing, Maintenance, EHS, vendors, and project personnel.
• Document protocol discrepancies and deviations per AML procedures.
• Provide technical input to impact assessment, troubleshooting, root-cause, retesting strategy, corrective actions, and closure.
• Prepare IQ/OQ/PQ reports or combined qualification summaries with scope, results, discrepancies, resolutions, and conclusions.
• Assemble complete execution packages with protocols, raw data, attachments, discrepancy records, and final reports.
• Support review comments and close documentation within the agreed schedule.

Skills

IQ/OQ/PQ execution

Commissioning

Bilingual Spanish/English

AML systems usage

Education

Bachelor’s Degree in Science or Engineering

Tools

KNEAT

CDOCS

Trackwise

Job description

FITS LLC in Puerto Rico is seeking a qualified candidate to support commissioning, qualification, and validation activities for process equipment, facilities, and utilities. The role requires a science or engineering background and at least two years of relevant experience, with fluency in Spanish and English to coordinate across teams.

The position involves reviewing and executing IQ/OQ/PQ protocols, preparing reports, and assembling execution packages, while collaborating with diverse project