Validation Specialist

Responsibilities

• 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.
• Detail-oriented with a strong compliance mindset.
• 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.
• May require off-shift or weekend support during execution windows.

Qualifications

• Must have experience supporting medical device manufacturing under ISO 13485.
• Preferred qualifications include 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.

Required Technical Skills

• 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.
• Devise and implement risk-based validation methodologies aligned with GAMP 5 and industry best practices.
• 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.

Benefits

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.