GxP Equipment Qualification Specialist

Veg Group; Aguadilla (PR); On-site; USD 70,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Manufacturing Equipment Specialist to lead qualification of assigned equipment, such as biological safety cabinets and scales, in a GMP/GxP environment.

You will review user requirements, develop and execute IQ/OQ protocols, document results, manage deviations, and assemble complete qualification packages with traceability matrices and reports. Strong English communication is required; Spanish preferred for site interaction.

Qualifications

• Strong written and verbal communication in English.
• Experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience in pharmaceutical, biologics, or GxP environments.
• Working knowledge of GMP, GDP, FDA cGMP requirements, EU GMP Annex 1, 21 CFR Part 11, ISPE/GAMP.
• Ability to interpret user requirements, design documents, and vendor documentation.
• Ability to write clear qualification documents and reports and perform testing accurately.

Responsibilities

• Lead qualification of equipment including biosafety cabinets and scales.
• Prepare IQ/OQ protocols and manage routing for approval.
• Perform field walkdowns and document reviews to confirm readiness.
• Document discrepancies and coordinate retesting when needed.
• Assemble qualification packages and generate traceability matrices and reports.
• Maintain weekly forecast, deliverable tracker, and time records.

Skills

English communication

Qualification execution

Documentation writing

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. seeks a Manufacturing Equipment Specialist to lead qualification of assigned equipment, such as biological safety cabinets and scales, in a GMP/GxP environment.

You will review user requirements, develop and execute IQ/OQ protocols, document results, manage deviations, and assemble complete qualification packages with traceability matrices and reports. Strong English communication is required; Spanish preferred for site interaction.