Autoclave and Supporting Utility Qualification Specialist

Pinnaql

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

Posted 9/30/2026full-timeSan Juan • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing qualification protocols and lifecycle documents within GxP environments, with a strong focus on compliance with GMP regulations and FDA cGMP requirements. Proficient in writing clear documentation and conducting thorough testing to ensure equipment and systems meet validation standards.

Highest-signal resume keywords

Qualification Protocol DevelopmentGMP Regulations KnowledgeValidation Plans ExecutionRisk-Based QualificationUser Requirements Specifications Interpretation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Qualification ProtocolsLifecycle DocumentsValidation TestingRisk AssessmentsData Integrity PrinciplesGxP ComplianceControl NarrativesCalibration RecordsDiscrepancy DocumentationRequirements Traceability Matrices

Soft Skills

Strong Written CommunicationStrong Verbal Communication

Industry Keywords

FDA cGMP RequirementsEU GMP Annex 121 CFR Part 11ISPE/GAMP PrinciplesGood Documentation PracticesPharmaceutical IndustryBiologics Industry

About the role

Key responsibilities & impact

Lead qualification of the autoclave in San Juan and associated water and Clean Steam Generation systems within the approved qualification boundary
Review facility, design, commissioning, vendor, maintenance, calibration, operating, and prior qualification documentation
Perform field assessments, walkdowns, and document reviews to confirm equipment and 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 including installation and utility verification, controls and alarm testing, cycle parameter testing, chamber distribution/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, indicators, sampling, laboratory support, safety requirements, and execution prerequisites
Generate, route, execute, and finalize IQ/OQ protocols using company procedures and document control processes
Document discrepancies, exceptions, and deviations; coordinate corrective actions and authorized retesting
Assemble complete, inspection-ready qualification packages for review and approval
Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
Support review comment resolution and final approval of qualification deliverables
Maintain weekly forecasts, deliverable trackers, and time records

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 and execute testing accurately
Strong written and verbal communication skills in English
Spanish proficiency preferred for effective site interaction

Benefits

Comp & perks

Empowering, purpose-driven, supportive team environment
Equal opportunity employment