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
...Jtec HCM, Inc. specializes in providing Owner Representation, Project Management and Construction Management services for health providers.... ...Role Description This is a full-time on-site role for an Assistant Project Manager. The Assistant Project Manager will assist in...
...Our client, a NYC-based multi-billion-dollar hedge fund manager running a long/short equity strategy, with a lean, collaborative team is hiring. The firm is seeking an experienced Fund Accounting/Trade Operations professional to join its Finance team. This is a hands...
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Henry Ford St. John Childrens Hospital is seeking a full-time Pediatric Neurologist to join our growing Pediatric Subspecialty Division. The St. John Childrens Hospital is located on the Henry Ford St. John Hospital and Medical Center campus in Detroit, MI.This is an...
...installs partnership with facilities/vendors, preventive maintenance, and repair of wafer fabrication equipment, including plasma etchers, metal deposition tools Create troubleshooting guides specifically for repeated root cause diseases Routine review all equipment...