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.
...Delivery Associate / Driver No previous work experience required. Compensation: $21.50/hr... ...(a commercial driver's license (CDL) is not required) Consent to a drug test... ...communication skills Amazon has partnered with local Delivery Service Partners (DSPs),...
...Pre-Tunnel Inspection Department, you will be working on a team to help ensure quality assurance for our customers by inspecting garments as you process them through our steam tunnel. At UniFirst we have a 5-day work week, enjoy Saturday and Sunday off!! We have an immediate...
...customers. Our work includes security systems, surveillance cameras, access control, networking and Wi-Fi, audio/video, and lighting controls. Honeywell security installation, programming, and troubleshooting experience is a key qualification. Responsibilities...
...and our communities. We also offer competitive pay with excellent benefits , company events, PTO, 401K, and more. Plus, were pet... ...and as part of a larger team High proficiency with Microsoft Office and GSuite Ability to learn quickly and develop additional...
...Legal Interns Candidates must have completed at least one semester of and be currently enrolled in an accredited J.D. or LL.M. program to participate. Anticipated responsibilities include research and writing related to intellectual property, as well as other policies...