, and Guidelines e.g. GAMP5 guide. Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.... Well versed with Manufacturing, Quality and engineering system and their validations. Knowledge of Pharmaceutical / Life...
, and Guidelines e.g. GAMP5 guide. Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.... Well versed with Manufacturing, Quality and engineering system and their validations. Knowledge of Pharmaceutical / Life...
-functional SMEs in developing and promulgating the computer system validation methodology for radiopharma. Participates... to all aspects of computer system validation and applicable local processes and policies. Change Management during qualification...
Process Automation Computer System Validation and Data Integrity Engineer is an Automation Engineering role supporting the... delivery. Provide Process Automation reviews and influence Site Quality Procedures that impact computer systems...
oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV..., audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately...
-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team... member for our USA office (Indianapolis). Job Description: The Validation Engineer will manage various commissioning...
support and frontline troubleshooting. Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR... knowledge of cGMP and Computer System Validation (CSV) frameworks Ability to interpret process requirements and translate them...
, specifically related to packaging processes and equipment 1+ years of experience in GMPs and computer systems validation (CSV... of serialization with the different OEMs Technically understand the integration of the serialization system with the OEM, ensuring the...
understanding of Computer System Validation (CSV) for qualifying automation systems. In-depth knowledge of FDA regulations... for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial...
of Cybersecurity, patching and IT Life Cycle Management (LCM). Understanding of computer system validation. Physical Requirements... along with CSV for lab and process automation are enabled and maintained to successfully deliver novel Radiopharmaceutical...