C&Q Validations

Flexible & Integrated Technical Services, LLC•Juncos, PR

10d

About The Position

This role is for C&Q (Commissioning and Qualification) services within the Business Operations area. The ideal candidate will have a strong technical background in commissioning and qualification processes, protocol generation and execution, and be bilingual in Spanish and English. The position requires a customer-service oriented individual who is innovative and delivers high-quality results. The day-to-day responsibilities include incorporating prerequisite verification, managing test equipment, supporting document reviews, interpreting technical drawings, executing IQ, OQ, and PQ protocols, collecting objective evidence, coordinating with various stakeholders, documenting discrepancies, providing technical input for troubleshooting, preparing qualification reports, and assembling execution packages.

Requirements

Bachelor’s Degree in Science, or Engineering field
At least 2 years of proven experience in commissioning and qualification processes, protocol generation and execution.
Bilingual (Spanish and English).
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.

Nice To Haves

Treats everyone they meet like family, especially resources, clients and team members.
Customer service pro.
Full of bright ideas and eager to innovate.
Always bringing top-quality results to the table.

Responsibilities

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.
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.