Validation Engineer-III-SUB-AKS-002

Small Description:
The Validation Engineer III is responsible for ensuring that systems, laboratory instruments, controlled temperature units (CTUs), and processes meet regulatory and performance standards through comprehensive validation lifecycle management. The role includes protocol development and execution, change control management, deviation investigations, CAPA implementation, and maintaining compliance with FDA, ISO, and cGMP requirements in a Quality Control laboratory environment.

Job Responsibilities:
• Provide lifecycle management for Quality Control lab instruments and related software systems.
• Revise and/or obsolete validation documents and Standard Operating Procedures (SOPs).
• Provide validation services for laboratory analytical instruments and controlled temperature units (CTU), including writing, editing, executing protocols, and reviewing vendor validation documents in accordance with site validation requirements.
• Perform change control management activities, including authoring, performing, and tracking change actions.
• Create and perform investigations for Deviations and CAPAs.
• Perform instrument periodic reviews.
• Escort onsite vendors performing laboratory instrument maintenance.
• Design and execute validation protocols (IQ/OQ/PQ) for equipment, utilities, and processes.
• Analyze test data and determine whether systems meet predefined acceptance criteria.
• Document validation activities and maintain records in accordance with regulatory guidelines.
• Collaborate with cross-functional teams to support product development and process improvements.
• Ensure compliance with industry standards such as FDA, ISO, and cGMP.
• Participate in audits and inspections, providing validation documentation and responses.
• Stay current with validation trends, technologies, and regulatory updates.

Skills:
• Strong analytical and problem-solving abilities.
• Knowledge of validation principles, quality systems, and regulatory requirements.
• Proficiency in statistical analysis tools and validation software.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple projects.
• Familiarity with laboratory and manufacturing environments.

Qualification:
• Bachelor’s degree in Engineering, Life Sciences, or a related field required.
• 5–7 years of experience in validation, quality assurance, or process engineering.