- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility ... validation , and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation , process validation ,… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... landscape and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical,… more
- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for ... development organization, there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System ... manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements… more
- Cipla (Fall River, MA)
- …documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive,… more
- Syner-G BioPharma Group (Boston, MA)
- …production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV.Knowledge, ... (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems , equipment, and processes for (re)qualification/(re)verification.Support validation … more
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and… more
- Sumitomo Pharma (Phoenix, AZ)
- …in Program & Project Management, including the Software Development Lifecycle and Computer Systems Validation process Excellent communication skills The ... which support their business objectives and operational demands Continuously assess current systems environment and identify changes (process and/or system ) that… more
- Intel (Hillsboro, OR)
- …protocols, strong platform-level debug skills, and a passion for validating complex systems at scale. Key Responsibilities Own validation strategy, test ... Details: Job Description: We are seeking a High-Speed Interconnect Validation Engineer to lead end-to-end validation of...high-speed I/O fabrics that power modern AI and HPC systems . The ideal candidate has deep technical knowledge of… more
- Takeda Pharmaceuticals (Minneapolis, MN)
- … enhancements. You'll gain hands-on experience in operational technology and computerized systems validation - critical areas that ensure product quality and ... As an Engineering Validation Intern - Operational Technology and Computerized Systems Validation , you will have the opportunity to: Gain exposure to… more
- World Wide Technology (Maryland Heights, MO)
- Project Validation Architect Why WWT? Founded in 1990, World Wide Technology (WWT), a global technology solutions provider leading the AI and Digital Revolution, ... greatest solutions across all technology domains. What will you be doing? As a Validation Architect, you will play a dynamic role interfacing with many teams through… more
- Apple (Beaverton, OR)
- …Common Firmware Environment (CFE) and other platform software for Apple silicon validation organization. Develop system software to exercise power saving feature ... development, bare metal, RTOS and/or Linux Solid understanding about ARM specification, computer architecture, operating system Experience in boot code, CPU &… more
- UnitedHealth Group (Minnetonka, MN)
- …us to start Caring. Connecting. Growing together . In this position as a DRG/CVA Validation Auditor RN , you will apply your expert knowledge of the MS-DRG and ... APR-DRG coding/reimbursement methodology systems , ICD-10 Official Coding Guidelines, and AHA Coding Clinic...mouse, handling other objects, long periods working at a computer Have a secluded office area in which to… more
- Texas Instruments (Phoenix, AZ)
- …could work in one of the following roles based on degree Validation /Characterization Engineer Product Engineer Test Engineer You'll have direct involvement in the ... for markets such as industrial, automotive, personal electronics, communications equipment and enterprise systems . At our core, we have a passion to create a better… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes...Clinical/Manufacturing systems .Minimum of a Bachelor's Degree in Computer … more
- Honeywell (Phoenix, AZ)
- … Systems development activities and analysis in an area of all aircraft sub- systems Systems validation & verification- Prepare detailed test plans, ... knowledge of Anthem architecture, Anthem processes and tools Support execution of Systems Validation and Verification execution on target bench and creation… more
- AUROBINDO (Durham, NC)
- …in risk assessments and impact analysis for system changes.Support validation activities including IQ/OQ/PQ for IT systems .Maintain QA documentation in ... systems .Excellent documentation and communication skills.Familiarity with risk-based validation approaches.Education & ExperienceBachelor's Degree in Computer … more
- Oracle (Phoenix, AZ)
- …and recommend long-term solutions Bachelor's degree or equivalent experience in Information Systems , Computer Science, Computer Engineering, or Software ... with the focus on excellence. Oracle's Federal Operations Production Service System Administrators provide system implementation, support, monitoring, and… more
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