Manufacturing Equipment Qualification Specialist

Veg Group; Aguadilla (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks a Manufacturing Equipment Specialist to lead qualification activities for critical equipment across GMP environments.

You will verify equipment details, test controls, and reference data to support qualification strategies. Responsibilities include preparing IQ/OQ protocols, coordinating reviews, executing protocols, documenting deviations, and assembling complete qualification packages with traceability.

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience developing and executing qualification protocols or CSV lifecycle documents.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Knowledge of GMP regulations, GDP, FDA cGMP requirements and ISPE/GAMP principles.
• Ability to interpret specifications, drawings, and vendor documentation.

Responsibilities

• Lead qualification of assigned equipment, e.g., biological safety cabinets and scales.
• Verify equipment identification, installation, utilities, materials of construction, components, manuals, drawings, calibration status, and PM information.
• Test controls, operating ranges, displays, alarms, interlocks, safety functions, and recovery behavior.
• Prepare IQ/OQ protocols and incorporate review comments to obtain approval for execution.
• Execute protocols per company procedures and GDP, document discrepancies, and support resolution.
• Assemble complete qualification packages and generate traceability matrices and summary reports.

Skills

English communication

Spanish preferred

Technical writing

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. (V&EG) seeks a Manufacturing Equipment Specialist to lead qualification activities for critical equipment across GMP environments.

You will verify equipment details, test controls, and reference data to support qualification strategies. Responsibilities include preparing IQ/OQ protocols, coordinating reviews, executing protocols, documenting deviations, and assembling complete qualification packages with traceability.