- Charles River Laboratories (Memphis, TN)
- …protocols]. * Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity. * Collaborate with cross functional teams ... Managers, vendors, etc). * Provide guidance and support on Computer System Validation (CSV) practices, helping others...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The **Lead Computer System Validation (CSV) Engineer** supports the successful implementation of manufacturing ... the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions, this individual… more
- Terumo Neuro (Aliso Viejo, CA)
- …quality assurance such as design control, risk analysis, design verification, design validation , process validation , test method validation , statistical ... + Work with R&D on design verification and design validation testing of new products. + Work with R&D...and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4.… more
- Colgate-Palmolive (Sanford, ME)
- …21 CFR 210 & 211, and experience in working in a regulated industry (ie FDA ) + Working knowledge of SAP, validation software (KNEAT), InBatch or similar ... internal /external networking. Key technical deliverables include; process optimization and validation , technical transfer including SAP item setup and Management of… more
- West Pharmaceutical Services (Exton, PA)
- …guidance on regulatory and industry standards concerning data integrity, including computer system validation , audit trails, electronic signatures, and data ... for regulatory and industry expectations in terms of data integrity requirements: computer system validation , audit trail, electronic signature, data storage and… more
- GRAIL (Durham, NC)
- …control software). + Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with **QMS and FDA ... power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's… more
- Abbott (Milpitas, CA)
- …addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control ... **The Opportunity** The Embedded Software Engineer oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA… more
- Sanofi Group (Morristown, NJ)
- … computer science) or previous experience in Pharmacovigilance Safety Database/ validation experience working in a highly regulated environment + Additional ... into the appropriate technical language to ensure that configuration, operations, validation , and/or analytic reporting deliverables meet business needs. This role… more
- Sokol Materials & Services (Skillman, NJ)
- …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... risk-based validation approaches. + Strong analytical, problem-solving, and communication skills....Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up… more
- West Pharmaceutical Services (Scottsdale, AZ)
- …of local site and business unit level QMS to ensure strict compliance with FDA 21CFR Part 820, ISO 13485, EUMDR, GxP, and relevant regulatory requirements. + ... on QMS performance to senior management. + Align activities with regulatory guidelines such as FDA 21CFR Part 820, ISO 13485, GxPs, and ISO 14971. + Adhere to all… more