Process Validation Engineer

• Defines validation strategy and requirements and ensure implementation.
• Review and approve validation requirements, master validation plan/report, validation protocols/ reports to support Process Validation and re-validation activities for New Product Introduction and Sustaining in accordance with FDA/AAMI/ISO/EN guidelines/standards.
• Actively participate during all phases of process qualification.
• Evaluate projects, provides guidance and technical information to others to generate protocols, execute qualification activities, analyze resulting data and to prepare reports.
• Lead and assist in all assigned qualification activities.
• Determine and establish requirements for qualification activities.
• Make independent decisions related to qualification activities.
• Participate in the generation and/or update of the validation plan and validation status lists.
• Review qualification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.
• Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.
• Bring critical exceptions or deviations to management's attention and propose compliant solutions.
• Lead trouble shooting activities for deviations and non-conformances
• Recommend to management as to the acceptance and release of qualified systems.
• Initiate and enforce necessary improvements and corrections; attend team meetings pertinent to validation.

Requirements:

• Write and revise standard operating procedures describing validation principles and activities.
• Provide training and guidance to applicable operators and technicians
• Initiate, execute, and track completion of Change Control requests.
• Establish priorities and schedule activities to ensure timelines and milestones are met.
• Participate in external audits of providers and labs.
• Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products
• Responsible for establishing validation standards
• Coordinate with required personnel affected by validation testing
• Review and approve validation execution reports, and associated deviations
• Analyzes test results
• Reviews and prepares compliance reports
• Directs validation activities
• Resolves testing problems
• Makes adjustments or improvements to equipment and processes
• Creates databases to track validation activities
• Interprets customer requirements
• Develops validation schedules
• Conducts training and overseeing the work of validation technicians
• Keeps up to date on industry standards and regulations.