- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems . + Manage Computer System Validation ( CSV ) activities in alignment with global regulatory ... will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems ...and validation strategy for enterprise-level Document Management Systems (DMS) within the Life Sciences domain. You will… more
- Cardinal Health (Boston, MA)
- …+ Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation ( CSV ) methodologies. + Define technical ... You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team… more
- Bristol Myers Squibb (Devens, MA)
- …four (4) years focused on quality assurance, validation , or compliance for computerized systems . + Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR ... Cell Therapy Facility (CTF) through managing the computerized system validation ( CSV ) activities / major projects and...& Job Responsibilities:** + Gain a thorough understanding of computer systems deployed at Devens CTF. +… more
- Insight Global (Danvers, MA)
- … System Validation ( CSV ) Engineer to ensure that all computer systems and software applications comply with industry standards and regulatory ... validation plans for new and existing GxP computer systems and digital solutions. -Lead and/or...years of related experience in computer system validation . -Hands-on experience with CSV in regulated… more
- Astellas Pharma (Westborough, MA)
- …Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The Computer System Validation ( CSV ) Lead is responsible for ... **Principal Computer System Validation Specialist** Do you...developing, executing, and maintaining the validation strategy for GxP-regulated computerized systems supporting… more
- Cognizant (Boston, MA)
- …or life sciences domain, including 2+ years in a management role. + Expertise in Computer System Validation ( CSV ) and Computer Software Assurance (CSA). ... Lead** , you will make an impact by leading validation and testing initiatives across life sciences systems...and digital documentation. + Collaborate with stakeholders to establish validation protocols and ensure adherence to CSV /CSA… more
- Bristol Myers Squibb (Devens, MA)
- …projects, preferably in biologics or cell therapy manufacturing. + Strong understanding of CSV ( computer system validation ), data integrity, and regulatory ... of laboratory informatics systems (eg, LIMS, CDS, SDMS, ELN) and corresponding validation requirements. + Demonstrated experience leading complex IT or digital… more
- Skyworks (Woburn, MA)
- …attention to details in documentation. Education Pursuing Graduate degree in Computer Science, Industrial Engineering, Information Systems , or another equivalent ... Nearest Major Market:WoburnNearest Secondary Market:Boston Job Segment: Java, Intern, Systems Analyst, Industrial Engineer, Computer Science, Technology, Entry… more
- Candela Corporation (Marlborough, MA)
- …direct accountability for DQA, SQA, Test Method Validation (TMV), Computer System/Software (non-product) Validation ( CSV ), Periodic/Ad-hoc risk reviews, ... for NPI Design Controls, Design Transfer, and the successful validation /maintenance/improvements linked to both CMO production and other supplied material.… more
- Cardinal Health (Boston, MA)
- …Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/ CSV ( Computer System Validation ), DSCSA(Drug Supply Chain ... products company. We provide customized solutions for hospitals, healthcare systems , pharmacies, ambulatory surgery centers, clinical laboratories, physician offices… more