Autoclave and Supporting Utility Qualification Specialist

Validation & Engineering Group, Inc.

. Lead qualification of the autoclave located in San Juan and associated water and Clean Steam Generation systems .

Posted 9/30/2026full-timeSan Juan • Puerto RicoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing qualification protocols and lifecycle documents in compliance with GMP regulations and industry standards. Proficient in risk-based qualification, validation, and documentation practices within pharmaceutical and biologics environments.

Highest-signal resume keywords

Qualification Protocol DevelopmentGMP Regulations KnowledgeRisk-Based QualificationValidation Plans ExecutionUser Requirements Specifications Interpretation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Qualification ProtocolsCSV Lifecycle DocumentsRisk AssessmentsIQ/OQ/PQ ProtocolsData Integrity PrinciplesControls and Alarm TestingCycle Parameter TestingLoad Penetration StudiesDiscrepancy RecordsRequirements Traceability Matrices

Soft Skills

Strong Written CommunicationStrong Verbal Communication

Tools & Technologies

Document Control ProcessesCalibration RecordsFunctional Specifications

Industry Keywords

GxP EnvironmentsFDA cGMP RequirementsEU GMP Annex 121 CFR Part 11ISPE/GAMP PrinciplesGood Documentation Practices

About the role

Key responsibilities & impact

Lead qualification of the autoclave located in San Juan and associated water and Clean Steam Generation systems
Review facility, design, commissioning, vendor, maintenance, calibration, operating, and prior qualification documentation
Perform field assessments and walkdowns; confirm equipment, utility boundaries, interfaces, prerequisites, and readiness
Develop or revise lifecycle documents, including URS, risk assessments, Validation Plans, IQ/OQ/PQ protocols, data sheets, RTMs, discrepancy/deviation records, and summary reports
Define and execute qualification activities such as installation and utility verification, controls and alarm testing, cycle parameter testing, chamber distribution or mapping, load penetration studies, challenge testing, reproducibility, and acceptance criteria
Verify or qualify supporting water and Clean Steam Generation systems, including generation, distribution, quality attributes, sampling, monitoring, controls, alarms, and interfaces
Coordinate equipment availability, approved loads, calibrated instruments, biological or chemical indicators, sampling, laboratory support, safety requirements, and execution prerequisites
Generate IQ/OQ protocols using Company procedures, templates, and document control processes; route protocols through approval
Execute approved protocols according to Company procedures and Good Documentation Practices
Document discrepancies, exceptions, and deviations; support assessment, corrective actions, resolution, and authorized retesting
Assemble complete, inspection-ready qualification packages
Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
Support review comment resolution and final approval of qualification documents
Maintain weekly forecasts, deliverable trackers, and time records
Perform protocol execution and field activities on site in San Juan; document development may be remote when authorized

Requirements

What you’ll need

Bachelor's degree in Engineering or related field
Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed
Prior experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments
Working knowledge of applicable GMP regulations, Good Documentation Practices (GDP), regulatory guidance, data integrity principles, risk-based qualification and validation, and relevant industry standards
Knowledge of FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles
Ability to interpret User Requirements Specifications, design documents, drawings, functional specifications, control narratives, vendor documentation, calibration records, and commissioning evidence
Demonstrated ability to write clear qualification or validation documents and reports
Ability to execute testing accurately in the applicable field or computerized environment
Strong written and verbal communication skills in English
Spanish proficiency preferred for effective site interaction
Periodic visits to the San Juan equipment location and Aguadilla facility required
Protocol execution and other field activities must be performed on site in San Juan

Benefits

Comp & perks

Equal opportunity employer
Supportive, purpose-driven team environment
Opportunity to make a meaningful difference in healthcare and technology
Remote document development when authorized
People-first culture emphasizing empowerment and bold ideas