Validation Specialist

Education: 
•      High School Diploma
  
Required skills:
• 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 line.
• Exposure to validation remediation or regulatory commitment work
• Detail oriented with a strong compliance mindset
• Ability to work independently under contract deliverables
• Strong problem solving and root cause analysis skills
• Effective communication with cross-functional teams
• Comfortable working in production and controlled environments

Role Overview:
• The Validation Specialist 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 is focused on hands on execution of validation deliverables to support equipment, process, utility, and computerized system readiness in accordance with FDA, ISO, and cGMP requirements.
• The specialist will work closely with Engineering, Quality, Automation, IT, and Operations 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 pharma and medical device manufacturing systems
• Support validation of:
o Manufacturing and packaging equipment
o Utilities (compressed air, clean utilities, environmental controls)
o Computerized systems (automation, data acquisition, MES, LIMS, vision systems)
• Apply risk-based validation methodologies aligned with GAMP 5 and industry best practices
• Author, execute, review, and route validation documents within KNEAT Gx
• Maintain end-to-end traceability between:
o User Requirements (URS)
o Risk Assessments
o Test cases and protocols
o 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:
o FDA cGMP regulations (21 CFR Parts 210/211, Part 11)
o ISO 13485 (Medical Devices)
o 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
• 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

Work Conditions: 
• 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 area