- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… more
- Reynolds American (Winston Salem, NC)
- …Experience supporting Product, R&D, and regulatory business teams, with understanding of FDA Computer System Validation requirements and validated ... and resourcing requirements. **What are we looking for?** + Bachelor's degree in Computer Science, IT, Software Engineering, or related field; Master's degree in … more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Bristol Myers Squibb (Devens, MA)
- …. **Summary:** We are seeking a highly skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to join our team at the Devens Cell Therapy ... Engineer will be responsible for managing the computerized system validation (CSV) activities for major projects to comply with.... **Key Responsibilities:** + Gain a thorough understanding of computer systems deployed at Devens CTF. + Develop and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more
- NTT DATA North America (Highland Heights, KY)
- …Risk Assessments, Validation Summary Reports, SOPs, and technical specifications. Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex ... sequencers, PCR systems). Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation . Regulatory compliance with FDA 21 CFR Part 11, EU Annex… more
- Belcan (Indianapolis, IN)
- …* Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation . * Assures compliance with SOPs upon ... Quality Validation Specialist Job Number: 360132 Category: Quality Engineering... Specialist ensures current Good Manufacturing Practices (cGMP) and FDA /Quality Systems are adhered to throughout the evaluation, review… more
- Bristol Myers Squibb (Devens, MA)
- …utility systems, process automation systems and manufacturing execution system recipes, computer systems, and laboratory instrumentation. + Implement validation ... to work and manage within a regulatory environment. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory… more
- NTT DATA North America (Highland Heights, KY)
- …life cycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports. + Ensure compliance with FDA 21 CFR ... qualification (DQ, IQ, OQ, PQ).** + Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP,...discipline required. + Master's degree or professional certifications in Computer System Validation (CSV), GAMP 5, or… more
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