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
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