C&Q Validations

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

For C&Q services in the Business Operations area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Science, or Engineering field with at least 2 years of proven experiencein commissioning and qualification processes, protocol generationand execution.
• Bilingual (Spanish and English.)
• Shift: Administrative and according to business needs.
• Experience in:
  • Demonstrated experience in commissioning, qualification, and validation within a regulated biopharmaceutical or pharmaceutical manufacturing environment.
  • Demonstrated ability to independently develop, execute, and report IQ, OQ, and PQ activities for process equipment, facilities, or utilities.
  • Ability to use AML-designated electronic document, training, and project systems after access and training are completed such as KNEAT, CDOCS, Trackwise among others.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• Incorporate prerequisite verification, instrument and calibration status, materials, test equipment, safety controls, data recording requirements, and discrepancy handling.
• Support review-cycle comments and revise documents through approval and readiness for execution.
• Ability to interpret P&IDs, equipment drawings, specifications, control narratives, vendor documents, calibration records, and applicable automation documentation.
• Execute approved IQ, OQ, and PQ protocols for process equipment, facilities, and utilities in accordance with the authorized schedule.
• Perform installation verification, component and instrument checks, drawing verification, configuration verification, alarms/interlocks/challenges, operating-range testing, functional testing, performance testing, and other approved protocol activities as applicable to the assigned system.
• Collect complete, attributable, contemporaneous, original, accurate, and legible (ALCOA +) objective evidence, including test data and approved attachments.
• Coordinate execution with System Owners, Engineering, Automation, Quality, Manufacturing, Maintenance, EHS, vendors, and other project personnel as required.
• Document protocol discrepancies and deviations in accordance with applicable AML procedures.
• Provide technical input to impact assessment, troubleshooting, root-cause evaluation, retesting strategy, corrective actions, and closure documentation.
• Prepare IQ, OQ, and PQ reports or combined qualification summary reports, as assigned, 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.
• Support review comments and close documentation within the agreed schedule.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?