Senior Quality/Process Validation Engineer

Responsibilities :

• Evaluate and validate equipment and processes in the development and production of medical products to ensure efficient and compliant operations.
• Author, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA / AAMI / ISO / EN guidelines / standards.
• Actively participate in all phases of process qualification.
• Evaluate projects, provide guidance and technical information, generate protocols, execute qualification activities, analyse data, and prepare reports.
• Lead all assigned qualification activities and make independent decisions related to these activities.
• Participate in the generation and / or updates of the validation plan and validation status lists.
• Review qualification packages for completeness, accuracy, compliance, and sound rationale.
• Compare results against acceptance criteria and collaborate with departments to resolve exceptions and deviations.
• Bring critical exceptions or deviations to management's attention and propose compliant solutions.
• Lead troubleshooting activities for deviations and non-conformances.
• Recommend acceptance and release of qualified systems to management.
• Initiate and enforce improvements and corrections; participate in team meetings relevant to validation.
• Write and revise standard operating procedures detailing validation principles and activities.
• Provide training and guidance to operators and technicians.
• Initiate, execute, and track completion of Change Control requests.
• Establish priorities and schedules to ensure timelines and milestones are met.
• Participate in external audits of providers and labs.
• Ensure systems run according to specifications and operate within regulations to produce quality products.
• Coordinate with personnel affected by validation testing.
• Compose validation execution reports and associated deviations.
• Monitor and test equipment, analyze and document test results, and prepare compliance reports.
• Direct validation activities, resolve testing problems, and make adjustments or improvements to equipment and processes.
• Create databases to track validation activities and develop validation schedules.
• Conduct training and oversee the work of validation technicians.
• Maintain instrumentation and equipment and stay current on industry standards and regulations.

Requirements :

• Typically requires a minimum of 6-8 years of experience in process validation or related fields.
• Knowledge of statistical tools and methodologies.
• Proficiency with electronic assembly, PCB operations, testing, inspection, and mechanical / electrical tools.
• Strong office skills, including data entry and proficiency with office software (word processing, spreadsheets, presentations).
• Demonstrated advanced functional and technical skills, troubleshooting and diagnostic abilities.
• Leadership skills to mentor other validation engineers and cross-functional teams.
• Certified Quality Engineer and Six Sigma Green Belt / Black Belt.
7 hours ago