- Merck & Co. (North Wales, PA)
- …IT delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation , and other global regulatory ... the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory… more
- Merck & Co. (Lower Gwynedd, PA)
- …and operational and informational technology systems .Apply deep expertise in the computer system validation process of lab equipment, including the conduct ... (from onboarding and maintenance to retirement), and manage and improve the computer system validation of laboratory equipment. This individual should be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT system ... diseases and immune disorders. Summary Deliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS)… more
- Merck & Co. (Lower Gwynedd, PA)
- …operational objectives for the Regulated Robotics teamDrives the computer system validation efforts for all departmental automation systems and LIMS. -- ... scientific and technical expertise in regulated assay design, automation, development, LIMS systems , system validation , and execution of these in support of… more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling and stooping are required.-Proficiency in computer systems and applications including but not limited to:- ... contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems .Assist with execution of calibration, automation, validation and… more
- Merck & Co. (Rahway, NJ)
- …and recommendations to Senior LeadershipWork collaboratively with the IP Systems Administrator on the following:Database maintenance activities, including status ... checks and data validation , to minimize data discrepancies that would prevent accurate...critical detailsWorking knowledge using and maintaining common IP docketing systems ; including appropriate system policies, procedures, controls, and US/WIPO… more
- Merck & Co. (Rahway, NJ)
- …and high-quality deliverables.Effective analysis and report programming development and validation , utilizing global and therapeutic area (TA) standards and ... staff. Requirements: Minimum education required: Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or a… more
- Merck & Co. (North Wales, PA)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... on departmental strategic initiative teams Educational Qualifications :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or… more
- Twist BioScience (South San Francisco, CA)
- …of production processes, project management, Supply Chain andWarehouse Management, Validation , and Quality Systems . Prior experience supporting other ... for Twist Operations toensure a high quality of data throughout all systems where master data is used. Creates,reviews, and updates department Standard Operating… more
- Aequor (Northborough, MA)
- …handle high value product vials in various stages of packaging completion. Use computer -based systems for data collection, data analysis, timecards, e-mail and ... support from the Quality Assurance, Materials Management, Facilities Engineering, Validation , Metrology and Manufacturing Technical Support groups. In addition,… more
- Merck & Co. (North Wales, PA)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... strategic initiative teams Education and Minimum Requirement :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related… more
- Merck & Co. (South San Francisco, CA)
- …particularly in oncology. Experience with datasets from Akoya Phenocycler and/or Vectra systems , as well as comfort with image analysis commercial software and/or ... reusable analysis frameworks for imaging dataAssist in the development and validation of digital pathology infrastructure solutions for large file management… more
- Genmab (Plainsboro, NJ)
- …Product Managers and OwnersJob RequirementsEducationMinimum of a Bachelor's degree in computer science, information systems , engineering or related technical ... integral part of the product roadmaps and planning and embed code validation services in POD processes.Security Awareness: Actively promotes information security and… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... risks involved in processing steps related to equipment, facility/utility and computer systems validation . This role will help develop and/or review… more
- PCI Pharma Services (Bedford, NH)
- …and database management skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems /software/equipment supporting GMP ... Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and QC operations and… 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 ... will work with lab & process automation, large corporate systems , small biotech systems , across all functions...corporate policies and procedures related to all aspects of computer system validation and applicable local processes… more
- University of Washington (Seattle, WA)
- …Department of Laboratory Medicine and Pathology** has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** + ... development, manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status, and prioritize actions based on… more
- PACIV (Indianapolis, IN)
- …and compliance standards. If you're ready to step into a leadership role in computer systems validation and drive impactful change, the Principal ... About PACIV: We are a global leader in control systems integration and regulatory compliance engineering. For over two...CSV Program Lead to set up and oversee CSV ( Computer System Validation ) deliverables for a high-impact… more
- Bayer (Berkeley, CA)
- …utilities, facilities, SIP, temperature mapping validation experience is desired; + Computer systems validation experience is desired; + Prior experience ... of risk-based approaches to validation ; + Ability to set validation strategy for complex systems and execute validation plans and to drive them to… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …for validation activities including analytical instruments, enterprise and laboratory computer systems validation , facility, utility, systems , ... In this role, you will support the lifecycle of GxP equipment, instruments, computer systems , facilities, and IT infrastructure critical to both internal and… more
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