| Sr Process Validation Engineer, Austin, TX(Onsite) at Austin, Texas, USA |
| Email: [email protected] |
| From: Yogesh Sharma, StellentIT [email protected] Reply to: [email protected] Sr Process Validation Engineer Austin, TX Phone + Skype Job description: General Purpose: Evaluate and validate equipment and processes in the development and production of medical products to ensure efficient and compliant operations. Key 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, analyze 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. Qualifications: 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. Keywords: Texas Sr Process Validation Engineer, Austin, TX(Onsite) [email protected] |
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| Mon Aug 19 20:34:00 UTC 2024 |