Supporting IT compliance and validation initiatives, the full-time Computer Systems Validation Engineer will execute computer system validation activities, assist with IT compliance programs, and participate in regulatory audits while working onsite in Devens, MA. Key responsibilities Execute assigned computer system validation (CSV) and IT compliance activities aligned with team objectives Support the implementation of CSV processes and assist in analyzing process deficiencies under senior staff direction Participate in regulatory audits and inspections, generating timely responses to audit observations Required qualifications Bachelor's degree in Engineering, Science, Information Technology, or a related field with 1-3 years of relevant experience in Compliance and CSV Working knowledge of regulatory computer system validation requirements, including FDA and EMA guidelines Experience supporting quality systems, risk management, and deviation management in a regulated environment Developing ability to represent the department before stakeholders and management Willingness to support interactions with regulatory agencies under senior staff guidance
...What you will do The AI Vision Systems Specialist is responsible for designing, developing, and deploying computer vision solutions that enable intelligent automation... ...concept (PoC) solutions in lab environments, validate them, and drive the integration of core solutions...
...DescriptionSpectrum Healthcare Resources is currently seeking a Part-time Occupational Health Registered Nurse to join our team in... ...federal employeesnot the general public.Position Highlights16 hours per week, MondayThursday, 8:00 AM 12:00 PMNo nights, weekends...
...Computer Systems Validation Engineer United States - Remote This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape...
...execution of risk-based CSV strategies for new system implementations, software upgrades,... ..., configuration specifications, validation protocols, traceability matrices, and validation... .... The CandidateBS.in Engineering, Computer Science, Life Sciences or another related...
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