Validation Specialist

Introduction:

The Validation Specialist (Contract) will support pharmaceutical and medical device operations by executing and maintaining compliant validation activities using Kneat Gx as the electronic validation lifecycle management system. This role will involve hands-on execution of validation deliverables to ensure equipment, processes, utilities, and computerized systems are ready in accordance with FDA, ISO, and cGMP requirements. The specialist will collaborate with various departments to ensure systems and equipment are validated, audit-ready, and capable of supporting safe, compliant production.

Responsibilities:

• Execute IQ, OQ, PQ, requalification, and validation maintenance activities for pharmaceutical and medical device manufacturing systems.
• Validate manufacturing and packaging equipment, utilities, and computerized systems.
• Apply risk-based validation methodologies aligned with GAMP 5 and industry best practices.
• Collaborate with cross-functional teams to provide on-floor support during commissioning, troubleshooting, and validation execution.
• Support site initiatives such as new equipment introduction, line upgrades, remediation efforts, and capacity expansions.
• Maintain validation documentation in a state of continuous inspection readiness.

Requirements:

Required Qualifications:

• Experience with FDA, IQ, medical device, OQ, PQ, and validation processes.
• Strong technical skills in KNEAT Gx Lifecycle Management.
• Ability to author, execute, review, and route validation documents within KNEAT Gx.
• Experience in deviation, change control, and CAPA support.
• Knowledge of regulatory compliance including FDA cGMP regulations, ISO 13485, and QMS requirements.

Preferred Qualifications:

• Experience supporting medical device manufacturing under ISO 13485.
• Experience with automation and controls (PLC/SCADA), vision systems, or MES.
• Experience supporting high-speed packaging or assembly lines.
• Exposure to validation remediation or regulatory commitment work.

Additional Details:

• Industry: Pharmaceutical & Medical Devices.
• Contract Type: Contract (On-site/Hybrid, as required).
• Duration: Contract basis (length defined by project needs).
• On-site support in a controlled GMP manufacturing environment.
• May require off-shift or weekend support during execution windows.
• PPE and gowning requirements may apply depending on the area.