Contract Validation Specialist (Kneat Gx, ISO 13485)

Accord Technologies Inc; Marion (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Accord Technologies Inc in Marion, NC is seeking a Validation Specialist (Contract) to execute and maintain compliant validation activities for pharmaceutical and medical device systems using Kneat Gx, ensuring 21 CFR Part 11 compliance and end-to-end traceability.

You will collaborate with Engineering, Quality, Automation and IT to validate equipment, utilities, and computerized systems, perform IQ/OQ/PQ, and support deviations, CAPA, and regulatory inspections in a GMP environment on site.

Qualifications

• Hands-on validation execution for pharma and medical device systems.
• Maintain compliant validation activities aligned with FDA, ISO, and cGMP requirements.
• Work with cross-functional teams to ensure audit readiness and validated state.

Responsibilities

• Execute IQ, OQ, PQ, requalification, and validation maintenance for pharma/medical devices.
• Validate equipment, utilities, and computerized systems (MES, LIMS, vision).
• Maintain end-to-end traceability from URS to final reports and deviations.

Skills

Documentation

Collaboration

Problem solving

Attention to detail

Tools

KNEAT Gx Lifecycle Management

Job description

Accord Technologies Inc in Marion, NC is seeking a Validation Specialist (Contract) to execute and maintain compliant validation activities for pharmaceutical and medical device systems using Kneat Gx, ensuring 21 CFR Part 11 compliance and end-to-end traceability.

You will collaborate with Engineering, Quality, Automation and IT to validate equipment, utilities, and computerized systems, perform IQ/OQ/PQ, and support deviations, CAPA, and regulatory inspections in a GMP environment on site.