- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. ... This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry… more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Merck & Co. (Rahway, NJ)
- …Qualification and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary ... on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations...reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- Twist BioScience (South San Francisco, CA)
- …11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ ... are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic...DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Katalyst HealthCares and Life Sciences (San Mateo, CA)
- …environment. Strong understanding of 21 CFR Part 11, CSA guidelines, with 5 years in computer systems validation and testing. Flexibility to work across time ... Pharma experience preferred. Requirements: BE, Comp Science, BCA, BSE computer science. Testing/ Validation for System ... implementations. Experience in working with SaaS and Cloud systems in a GxP environment. Thorough knowledge of GxP… more
- Marvell Technology, Inc. (Santa Clara, CA)
- …experience with Linux and Windows OS and cross platform compatibility. Knowledge of computer system , ethernet protocol, physical device and DSP is a plus. ... trends, Marvell is a place to thrive, learn, and lead . Your Team, Your Impact Marvell continuously delivers the...cloud data center applications. As a hardware and silicon validation senior staff engineer at Marvell, you'll be helping… more
- Katalyst HealthCares and Life Sciences (Schaumburg, IL)
- …understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU ... 11 and other relevant regulations). Bachelor's degree or equivalent experience in computer science, information technology, or a related field. High degree of… more
- SpaceX (Irvine, CA)
- …curious engineer who will work alongside world-class cross-disciplinary teams ( systems , firmware, architecture, design, validation , product engineering, ASIC ... goal of enabling human life on Mars. SR. SERDES CHARACTERIZATION AND VALIDATION ENGINEER (SILICON ENGINEERING) At SpaceX we're leveraging our experience in building… more
- Astera Labs (Santa Clara, CA)
- …validation tests to quantify parametric device performance and margins over all system conditions. The validation team holds customers' requirements in the ... and Ethernet semiconductor-based solutions and the COSMOS software suite of system management and optimization tools to deliver a software-defined architecture that… more
- Atlantic Health System (Pompton Plains, NJ)
- …when applicable 11. Calculates basic hemodynamic parameters using the recording computer . 12. Records catheterization events in the database computer . ... duties as assigned Qualifications 1.High School diploma or GED equivalent. LEAD - Specific Certification related to position or Associates Degree/Technical Degree… more
- Katalyst HealthCares and Life Sciences (Fernandina Beach, FL)
- …minimum of 4 years of experience in a regulated environment is required Lead computer software validation (CSV) project planning activities including ... changed programs/policies/procedures related to CSV and support SDLC & software validation policies, procedures and processes for computerized systems .… more
- General Motors (Warren, MI)
- …validation reports (CG190 etc.) Participate in Agile ceremonies (PI planning, DSU etc. Lead system test issue resolution initiatives Lead best practices ... technologies GM is introducing in Body electronics/Mechatronics space. What You'll do: Lead Body electronics feature, system and solution testing (manual and… more
- Wellfit Technologies (Irving, TX)
- …to meet growing technical and operational demands. The Opportunity: We are seeking a Lead Technical Business Analyst ( Lead TBA) to serve as the senior-most ... a true technical business analyst role, requiring deep fluency in APIs, system architecture, data integration methods, and software delivery lifecycles. This role… more
- Franciscan Missionaries of Our Lady Health System (Baton Rouge, LA)
- …and develops appropriate training utilizing behavioral objectives, lesson plans and validation testing to ensure the Sterile Processing department personnel receive ... by maintaining infection control techniques and monitoring situations which could lead to breaches in technique. Utilizes all equipment, supplies, facilities, and… more
- Amazon (Redmond, WA)
- …internet to customers and communities around the world, and we've designed the system with the capacity, flexibility, and performance to serve a wide range of ... Electrical Engineer responsible for ensuring electrical integrity across spacecraft harnessing systems , with a primary focus on test harnessing and a secondary… more
- Genpact (New York, NY)
- …(including running scoping and user requirement workshops, managing and facilitating data validation sessions) Lead end to end Celonis implementation in the ... role of Assistant Vice President - Process Mining Pre-sales Lead ! In this role, you will: Educate clients (and...Prepare and connect to the respective on-premise/ Cloud source system , extract and transform customers data and design process-… more
- Snohomish County, WA (Everett, WA)
- …materials and trains users on relevant new/changed program usage requirements. Designs computer systems to analyze data from other agencies. Modifies, designs ... automated financial system programs, and plan, coordinate and manage these systems through all phases of preparation of the county's general ledger, annual… more
- Tango Therapeutics (Boston, MA)
- …and troubleshoot problem areas as required Provide technical support, primarily for GxP-validated computer systems Ensure systems are validated in accordance ... Provide IT-specific guidance to departments for outsourcing needs Assume IT lead for installation, validation , troubleshooting, and management of hardware… more
