Facilities Qualification Engineer - IQ/OQ & Validation

Validation-; Isabela (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Facilities Qualification Specialist to lead qualification activities for rooms, architectural features, and supporting facilities within the approved scope.

You will review design docs, perform field walkdowns, generate IQ/OQ protocols, coordinate revisions, and assemble complete qualification packages for review. Fluency in English required; Spanish helpful.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience supporting qualification/CSV in GMP/GxP environments.
• Knowledge of GMP regulations, GDP, FDA 21 CFR Part 11 and ISPE/GAMP principles.

Responsibilities

• Review User Requirements, design documents, drawings and vendor docs to confirm qualification strategy.
• Perform field walkdowns and document readiness for qualification.
• Generate IQ/OQ protocols using company procedures and templates.
• Incorporate review comments and support protocol routing until approval.
• Execute IQ/OQ protocols and document discrepancies and deviations.
• Coordinate retesting after corrective actions within scope and hours.
• Assemble executed protocol and supporting evidence for review and approval.
• Maintain weekly forecast, deliverable tracker, and time records for the work.

Skills

English proficiency

Verbal communication

Written communication

Technical writing

Spanish (preferred)

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is seeking a Facilities Qualification Specialist to lead qualification activities for rooms, architectural features, and supporting facilities within the approved scope.

You will review design docs, perform field walkdowns, generate IQ/OQ protocols, coordinate revisions, and assemble complete qualification packages for review. Fluency in English required; Spanish helpful.