- Insmed Incorporated (NJ)
- …Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation , Quality Management Systems ... our Bridgewater, NJ or San Diego location. The Sr. Quality Engineer, Digital Systems Quality ...compliance with FDA, ICH, and EU regulations.Review and approve computer system validation (CSV) deliverables… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Insmed Incorporated (San Diego, CA)
- …This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency ... Design & Development: Lead the setup, development, and validation of EDC systems , including configuration settings,...GCP, 21 CFR Part 11, and CDISC ODM Standards.Data Quality & Compliance: Ensure EDC systems comply… more
- Aequor (Davie, FL)
- …Ensure systems meet GxP, FDA, and ISO standards through robust Computer Systems Validation (CSV) and documentation practices. Cross-Functional ... lead and support cross-functional initiatives across IT, OT, and controls systems in a GMP-regulated pharmaceutical manufacturing environment. This role will drive… more
- Merck & Co. (Rahway, NJ)
- …Adaptability, Analysis Reports, Analytical Instrumentation, Chemical Engineering, Chemical Technology, Computer System Validation (CSV), Data Analysis, ... testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and preventative actions.Document the… more
- Merck & Co. (North Wales, PA)
- …company clinical trials and assay metadata generated from these collections.Embed automated quality control checks and validation rules directly into data ... Master's (with 8 years) or Ph.D. (with 4 years) in bioinformatics, computer science, data science, engineering, data analytics, life sciences or other related… more
- Merck & Co. (Rahway, NJ)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Aequor (South San Francisco, CA)
- …QualityHelp ensure data accuracy, completeness, and consistency across different systems .Uphold data governance standards, ensuring that access to potentially ... complex datasets for deeper analysis.Contribute to the design, implementation, and validation of predictive models using machine learning and statistical techniques… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.-For assigned projects the position serves as the statistical programming ... Primary Activities: Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Lilly (Pleasant Prairie, WI)
- …management expertise to solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working ... of experience in Computer System Quality Assurance/ Computer System Validation...and project management experience + Demonstrated proficiency with GMP computer systems validation including regulations… more
- Haleon (Oak Hill, NY)
- … (CPV), Analytical Method validation , and Computer System validation + Collaborates across Engineering, Quality and Technical departments to ensure ... position is accountable for oversight, management, and delivery of all Validation Lifecycle components executed across Technical, Engineering, and QC departments at… more
- Sanofi Group (Swiftwater, PA)
- … and compliance policies and systems + Supply chain performance, related testing, validation , computer systems , quality systems , training, ... technical support to the company for project planning, process, systems and computer validation , aseptic...**Key Accountabilities:** + To ensure that a fully compliant Quality System Management (QSM) is implemented at… more
- NTT DATA North America (Highland Heights, KY)
- …or related discipline. Preferred certifications: Computer System Validation (CSV), GAMP 5 Practitioner, or Quality /Regulatory Compliance credentials. ... of hands-on expertise in the following skill areas: Analytical instrument systems validation (eg, spectroscopy, chromatography, protein analyzers, next-gen… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Computer System Validation Requisition ID: 71527 Date: Oct 3, 2025 Location: Exton, Pennsylvania, US Department: Laboratory Description: ... and leading the documentation for equipment that requires a computer system validation approach. You...maintain a state of control and compliance with established Quality Systems + Partner with D&T to… more
- Bristol Myers Squibb (Devens, MA)
- … quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and understanding of ... a highly skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to...four (4) years focused on quality assurance, validation , or compliance for computerized systems . +… more
- Bristol Myers Squibb (Summit, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **About the Role** This position will drive computer system validation activities for the Summit site ... process automation, and manufacturing environments are preferable* + 5+ years of Computer System Validation (CSV) experience in regulated pharmaceutical… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Jabil (Hunt Valley, MD)
- …across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance ... systems , and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation . +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
