2 days ago
Job Description: PSC Biotech is a leading life sciences consulting firm currently seeking a Mid to Senior Level Computer System Validation Engineer to support one of our clients in Los Angeles, CA. Responsibilities:Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements Perform computer system validation on manufacturing and laboratory equipmentTranslate system requirement specifications into executable validation protocols Provide support to executors of the protocols when needed Write reports summarizing system validation activities Requirements:BS degree in Computer Science, IT, Biomedical, Pharmacuetical, Chemical or any other variety of engineering with years of experience in Information Technology and computer system Compliance and/or Validation Protocol generation experience of laboratory/manufacturing systems, with a concentration of computerized systems validation Minimum of 5 years' experience with GAMP 5, CSV Excellent communication skills are a must Minimum 3 years of experience performing validation activities in a Title 21 CFR Part 11 compliant environment Report writing experience IQ, OQ, and CSV GxP experience in Pharma or Med Devices
PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.
11 days ago
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