Responsibilities :
- 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, analyse 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.
- Evaluate and validate equipment and processes in the development and production of medical products to ensure efficient and compliant operations.
Requirements :
- Typically requires a minimum of - 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.
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