Kneat Gx Validation Specialist

Katalyst CRO; Marion (NC); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

The Validation Specialist at Katalyst CRO in Marion, NC will execute and maintain compliant validation activities using Kneat Gx across equipment, processes, utilities, and computerised systems in line with FDA, ISO and cGMP requirements.

You will work with Engineering, Quality, Automation, IT and Operations to ensure systems are validated, audit-ready, and capable of supporting safe, compliant production, with on-site responsibilities and potential off-shift hours.

Competenze

• Hands-on validation execution across equipment, process, utilities, and computerized systems.
• Knowledge of GAMP 5 and industry best practices for risk-based validation.
• Experience supporting regulatory compliance (FDA, ISO) in pharma/medical device environments.

Mansioni

• Execute IQ, OQ, PQ, requalification and maintenance activities for pharma/medical device systems.
• Validate manufacturing equipment, utilities, and computerized systems per FDA/ISO/cGMP.
• Maintain end-to-end traceability among URS, risk assessments, test cases and reports in Kneat Gx.
• Support change control, deviations, CAPA, and regulatory inspections with validated documentation.
• Collaborate with Engineering, Quality, IT, Automation and Operations on validation activities.

Conoscenze

Validation execution

GAMP5

Regulatory compliance

Cross-functional collaboration

Strumenti

KNEAT Gx

Descrizione del lavoro

The Validation Specialist at Katalyst CRO in Marion, NC will execute and maintain compliant validation activities using Kneat Gx across equipment, processes, utilities, and computerised systems in line with FDA, ISO and cGMP requirements.

You will work with Engineering, Quality, Automation, IT and Operations to ensure systems are validated, audit-ready, and capable of supporting safe, compliant production, with on-site responsibilities and potential off-shift hours.