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.
...00 Job Category: Sales - Comparion Description Comparion Insurance Agency is hiring self-motivated, relationship-driven professionals... ..., field-based employee position. Applicants must be able to travel within their local community to meet with customers and build relationships...
...Requisition ID: 72113 About Whirlpool Corporation Whirlpool Corporation (NYSE: WHR) is a leading home appliance company, in constant pursuit of improving life at home. As the only major U.S.-based manufacturer of kitchen and laundry appliances, the company...
...Description Position Description: The research assistant will meet with the principal investigator on a weekly basis to discuss completed... ...Broker Research Project Description of Location: Remote Commitment: Temporary - Part-Time (10 hours/week) Start...
...Oct. 19 Accuracy matters. Speed matters. And for this team, getting both right is the goal. LaSalle Network is hiring Claims Adjudicators for a 10-month temporary opportunity supporting several medical claims adjustment projects. If you're comfortable working toward...
...Forklift Operating Positions AvailableStart your career today! Cold storage facility. We are hiring experienced forklift operators... ...material handlers job requirements:1 year of stand up forklift, cherry picker, and/or reach truck experienceHigh school diploma or GEDGood...