Facilities Qualification Lead – GMP/CSV (Pharma)

Validation & Engineering Group, Inc.; Isabela N00207-Air Base (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Facilities Qualification Specialist to lead room and facility qualification within approved scope, verifying boundaries, access, HVAC relations, and environmental conditions. You will generate IQ/OQ protocols, coordinate approvals, and execute testing per GDP.

Strong English skills required; Spanish preferred for site interaction. The role focuses on documenting readiness, reviewing design documents, and delivering complete qualification packages for

Qualifications

• Bachelor's degree in Engineering or related field.
• Hands-on experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or GxP environments.
• Knowledge of GMP regulations, GDP, FDA cGMP requirements, and ISPE/GAMP principles.
• Ability to interpret requirements, design documents, and commissioning evidence.
• Proven ability to write clear qualification or validation documents and reports.
• Strong English communication; Spanish proficiency preferred for site interaction.

Responsibilities

• Lead qualification of rooms, architectural elements, and facility features within the approved scope.
• Verify room boundaries, access points, HVAC relationships, and environmental conditions against drawings and requirements.
• Review readiness, punch items, and deviations that affect qualification acceptance.
• Generate IQ/OQ protocols using company procedures and templates; coordinate routing for approval.
• Execute IQ/OQ protocols per company procedures and GDP; document discrepancies and deviations.
• Coordinate retesting after corrective actions and assemble complete qualification package.

Skills

Communication skills

Spanish proficiency

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. seeks a Facilities Qualification Specialist to lead room and facility qualification within approved scope, verifying boundaries, access, HVAC relations, and environmental conditions. You will generate IQ/OQ protocols, coordinate approvals, and execute testing per GDP.

Strong English skills required; Spanish preferred for site interaction. The role focuses on documenting readiness, reviewing design documents, and delivering complete qualification packages for