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.
...Office Assistant Position Fish Window Cleaning North County is looking to hire a responsible part time Office Assistant for the Hazelwood... ...time and are looking to earn some additional income. No experience is necessary. Compensation: $10.00/hour Fish Window Cleaning
Job TitleTelephonic Nurse Case ManagerCompanyDavies North AmericaLocationHome - United StatesCompensation$78,000 - $83,000 / yearJob OverviewWe are seeking an experienced Telephonic Nurse Case Manager with a background in Florida Workers Compensation to join...
...THE OPPORTUNITY We are searching for a Diesel and Natural Gas Engine Service Technician to join our growing operations at our... ...across Construction, Electrical Power, Industrial, Marine Engines and Oil & Gas industries. We invest in training and development...
...Drain Technician Delco Storm & Sewer | Lansdowne, PA When a drain backs up or a sewer line stops flowing, homeowners need more than... ...technicians have the opportunity to work with professional drain-cleaning equipment, sewer cameras, hydro-jetting systems, and a team...
...Group INFINITI of the Palm Beaches is seeking an experienced Sales Manager to join our leadership team in West Palm Beach, Florida... ...package with performance-based incentives. ~ Medical, dental, and vision insurance. ~401(k) retirement plan. ~ Paid time...