Job-ID33104459Reference26-01807Job Summary: We are seeking a motivated and detail-oriented Computer System Validation (CSV) Engineer with 1–2 years of experience to support validation and compliance activities within the Pharmaceutical and Medical Devic e industries. The ideal candidate will assist with the validation of computerized systems in regulated GxP environments and ensure systems comply with applicable regulatory and quality requirements. The candidate should have a strong understanding of validation principles, documentation practices, data integrity, and regulatory expectations. Roles and Responsibilities:Support the planning, execution, and documentation of Computer System Validation (CSV) activities for GxP-regulated computerized systems. Support system impact assessments, risk assessments, and validation strategy development. Execute or assist with validation test scripts and document test results, deviations, and observations. Ensure validation deliverables comply with applicable FDA regulations, GxP requirements, 21 CFR Part 11, and Data Integrity principles. Assist with reviewing computerized systems for compliance with electronic records and electronic signatures requirements. Support deviation, change control, CAPA, and validation lifecycle activities as required. Collaborate with Quality Assurance, IT, Engineering, Manufacturing, and other cross-functional teams. Maintain accurate and complete validation records in accordance with company procedures and regulatory requirements. Participate in internal and external audits by providing appropriate validation documentation and support. Identify potential compliance gaps and assist in developing appropriate remediation activities. Stay current with relevant regulatory requirements, industry standards, and CSV best practices. Education & Experience: Bachelor's degree in engineering, Computer Science, Information Systems, Life Sciences, Pharmaceutical Sciences, or a related technical field. Relevant coursework or training in Computer System Validation, GxP, Quality Assurance, Regulatory Compliance, or Software Quality is a plus.1–2 years of professional experience in Computer System Validation (CSV), Validation, Quality Assurance, Compliance, or a related regulated industry. Experience supporting validation activities within the Pharmaceutical, Biotechnology, Medical Device, or other FDA-regulated industries is preferred.
...Barista PositionA Day in the Life:As a Barista, you will be provided with the skills and products to make the customer's day memorable... ...combined with engaged service is what drives customers to our Starbucks. As a Barista, you get to ensure they java nice day each time they...
...Nutrition Assistant IInspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit...
One of Central/Northern New Jerseys leading HVAC Mechanical Companies has an immediate need for a HVAC Service Manager to supervise and manage the commercial HVAC service department. Company offers a competitive compensation package including matching 401k, car allowance...
...Supervisor is not assigned, report to the LAD Managing Director. Manage influx of multiple... ...with close attention to time-sensitive information, and task deadlines and be able to... ...forms, and multiple databases through data entry, manual filing, building files, and other...
...Job Description Responsibilities \n \n Support electrical component engineering activities. \n Perform electrical analysis and schematic reviews. \n Support motors, actuators, generators, and power system components. \n Assist with component selection,...