Validation Specialist (KNEAT Gx)

Responsibilities

• Execute IQ, OQ, PQ, requalification, and validation maintenance activities for pharma and medical device manufacturing systems.
• Support validation of manufacturing and packaging equipment, utilities (compressed air, clean utilities, environmental controls), computerized systems (automation, data acquisition, MES, LIMS, vision systems).
• Apply risk-based validation methodologies aligned with GAMP 5 and industry best practices.
• KNEAT Gx Lifecycle Management: Author, execute, review, and route validation documents within KNEAT Gx.
• Maintain end to end traceability between User Requirements (URS), Risk Assessments, Test cases and protocols, Deviations and final reports.
• Ensure proper use of KNEAT Gx workflows, execution controls, and electronic approvals.
• Maintain compliance with 21 CFR Part 11 and data integrity expectations.
• Document and investigate validation deviations within KNEAT Gx.
• Support change control impact assessments affecting validated systems.
• Participate in root cause analysis and CAPA implementation when required.
• Ensure validation deliverables comply with FDA cGMP regulations (21 CFR Parts 210/211, Part 11), ISO 13485 (Medical Devices), and internal Quality Management System (QMS) requirements.
• Support regulatory inspections and customer audits by providing validation documentation and responses.
• Maintain validation documentation in a state of continuous inspection readiness.
• Cross-functional support: Collaborate with Engineering, Quality, IT, Automation, Manufacturing, and external vendors.
• 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.

Qualifications

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.