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- ...Job Description Job Description About the Role: As a CSV Specialist within the Professional, Scientific, and Technical Services industry, you will play a critical role in ensuring the integrity, compliance, and quality of computer system validation processes. Your...Suggested
- ...time all the time by transforming processes & technology into business advantages. ABOUT THE ROLE A Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in regulated environments are properly validated and maintained...Suggested
- ...capital automation projects. The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with SCADA and SAP systems. A background in the medical device industry is preferred. Key Responsibilities:...Suggested
- ...talent deserves great rewards. That’s why we offer a competitive compensation package and professional development. Summary The CSV Specialist is responsible for planning, executing, and documenting computer system validation activities for GxP-regulated...SuggestedWork at officeLocal area
- ...services & solutions on time all the time by transforming processes & technology into business advantages. ABOUT THE ROLE The CSV C&Q Technical Lead is responsible for defining, developing and delivering the CSV requirements, documentation and technical input...SuggestedFor contractorsFor subcontractor
- ...approving Change Control records through implementation verification and closure. Demonstrated experience reviewing qualification or CSV lifecycle documents and executed protocols, including discrepancies and summary reports. Working knowledge of applicable GMP...SuggestedInterim role
Validation & Engineering Group, Inc
Puerto Rico10 days ago - ...Knowledge of 21 CFR Part 11, GAMP 5, Good Documentation Practices (GDP), Change Control, CAPA, Deviations, and Validation Lifecycle (CSV). Experience in requirements gathering and analysis, business process mapping, gap analysis, user story creation, stakeholder management...Suggested
- ...support capital projects, and ensure all MES activities comply with cGMP standards and Data Integrity requirements. RESPONSIBILITIES CSV Execution: Support Computer System Validation (CSV) activities and evaluate and close change control documentation for eBR systems....SuggestedWork at office
- ...Bachelor's degree in Engineering or related field. Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed. Prior experience supporting qualification or CSV work in pharmaceutical...Suggested
- ...operational readiness, and closeout. Coordinate activities with Engineering, Manufacturing, EHS, Quality, Validation/C&Q, Automation, IT/CSV, Procurement, and Finance. Manage project budgets, commitments, expenditures, cash flow, forecasts, and estimates to complete....SuggestedFor contractors
- ...committed to work under the highest ethics standards for the following position: ~ Computer System Validation Specialist The CSV resource will provide risk-based validation services for Factorian and L7 ESP and for other GxP computerized systems assigned by the...SuggestedRemote work
- ...experience integrating robotic systems with PLCs, SCADA, MES, and/or ERP platforms. Strong knowledge of cGMP, 21 CFR Part 11, GAMP 5, and CSV lifecycle requirements in a pharmaceutical or regulated manufacturing setting. Proven ability to lead troubleshooting, root cause...SuggestedWork at office
- ...Bachelor's degree in Engineering or related field. Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed. Prior experience supporting qualification or CSV work in pharmaceutical...Suggested
$73.15k - $192.85k
...lifecycle. Ensure adherence to GMP/GxP, FDA 21 CFR Part 11, EU GMP Annex 11, Data Integrity (ALCOA+), GAMP 5, Computer System Validation (CSV), Computer Software Assurance (CSA), Collaborate with Quality Assurance, Validation, and Regulatory Affairs teams to ensure full...SuggestedPermanent employmentFull timeLocal area- ...pharmaceutical manufacturing or related regulated environments and understand the technical roles commonly required to support Automation, CSV, C&Q, Validation, Engineering, Manufacturing, and Project Management activities. This industry knowledge will allow the resource to...Suggested
- ...EMA, OSHA, EPA/EQB o 21 CFR Part 11, Engineering, IT, and Security standards ~Support execution of the Computer System Validation (CSV) lifecycle, including requirements, specifications, testing, and qualification. ~Support Performance Qualification (PQ) of equipment...For contractorsWork at officeFlexible hoursWeekend work
- ...systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles....
- ...knowledge. Experience with Cognex vision systems, SQL databases, or VMware environments. Knowledge of Computer System Validation (CSV) requirements. Familiarity with CMMS tools for maintenance tracking. SKILLS Technical Skills PLCs and computerized...Shift workNight shift
- ...Rico, the US, Europe and Asia, and translate them into technical specifications. Prepare and execute computer system validation (CSV) deliverables for reports and tools: requirements, design specifications, test scripts (IQ/OQ/PQ) and traceability, following GAMP 5...Full timeRemote work
