- University Health (Pleasanton, TX)
- …to regulatory reporting across Community First. Applies expertise in clinical, computer , and information sciences to identify, collect, process, and manage data ... include supporting PHM needs through ongoing management of data collection systems , developing procedures for monitoring, validating, and reconciling data for… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Lilly (Pleasant Prairie, WI)
- …expertise to solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working with Global ... cross-functional teams and project management experience + Demonstrated proficiency with GMP computer systems validation including regulations governing them… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …with systems like LIMS, MES, ERP, SCADA, or DCS (eg, Delta V) for computer systems validation engineers. + Advanced knowledge of equipment, systems , ... traceability matrices, and validation master plans. + Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to its assigned role. +… more
- System One (Princeton, NJ)
- …Lead Validation Specialist with a strong background in clinical systems and computer systems validation to join our growing team. In this role, ... Bring + Bachelor's degree required. + 8+ years of professional experience in computer systems validation within life sciences or clinical research. + 5+… more
- Lilly (Lebanon, IN)
- … in the pharmaceutical industry **Additional Preferences:** + Direct experience with Computer Systems Validation (GAMP5) and data integrity basic ... right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in...principles (ALCOA+). + Direct experience with computer system validation of automation … more
- PCI Pharma Services (Rockford, IL)
- …instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . ** Computer Validation Focus:** _Associate's Degree in ... to pioneer and shape the future of PCI. The ** Validation Analyst II** is responsible for overall validation... computer tasks and have some experience with computer systems considered to have an impact… more
- Jabil (Hunt Valley, MD)
- … activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory ... equipment for cGMP manufacturing. + Demonstrate SME-level knowledge of process/equipment validation , computer systems , standards, and GxP regulations.… more
- Cognizant (Boston, MA)
- …Oversee interoperability validation to guarantee seamless integration across platforms and systems . + Manage Computer System Validation (CSV) activities ... 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
- Curia (Albany, NY)
- …+ 401K program with matching contributions + Learning platform + And more! Responsibilities Computer Systems Validation + Manage multiple site and global CSV ... or related field + Minimum 3 years' experience in quality and computer systems validation and/or information technology Preferred + Experience in the… more
- Lilly (Lebanon, IN)
- … systems . **How You'll Succeed:** + Provide oversight and support of computer systems validation activities, including the review and approval of ... process to validate, maintain and retire new and existing computer systems . The position will be responsible...all documentation issued to support the validation /qualification of non-GMP and GMP systems , as… more
- Lilly (Indianapolis, IN)
- …Proficiency with IT systems development life cycle + Proficiency with Lilly Computer Systems Validation and demonstrated ability to right-size ... assigned functional areas, projects and/or systems comply with corporate computer system validation (CSV) standards. This includes providing consultation and… more
- Lilly (Indianapolis, IN)
- …in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). + Proven ability to support ... and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical skills to lead or… more
- Lilly (Indianapolis, IN)
- …IT applications/solutions.Industry experience. + **Additional Information:** + Experience maintaining Computer Systems Validation in line with ... enterprise architecture direction and standards. + Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity… more
- Bristol Myers Squibb (Summit, NJ)
- …Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. ... new equipment, facilities and utilities, as well as maintaining equipment systems in a qualified/validated state according to established policies and procedures.… more
- Lilly (Lebanon, IN)
- …C&Q / Verification and Validation oversight including automation and computer systems validation **Additional Preferences:** + Demonstrated knowledge ... and warehouse logistics + Previous experience with Manufacturing Execution Systems . + Previous use of KNEAT - or other...duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge… more
- Curia (Albuquerque, NM)
- …fostering skill development and knowledge sharing. + Support Validation and Computer Systems Validation activities to ensure compliance with industry ... maintenance, optimization, and strategic enhancement of control and data acquisition systems for manufacturing, packaging, and support equipment at the site. This… more
- Mentor Technical Group (NC)
- …environment is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in ... + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA ... coordinate and participate in compliant computer system validation (CSV) process for systems which require formal validation documentation in accordance… more
- ThermoFisher Scientific (Frederick, MD)
- …Engineer III, you will be responsible to interact with several departments to provide validation support for computer systems , equipment and processes, along ... activities are performed on time to keep all validated systems in a validated state. This role requires full-time...packaging or cGMP experience **Minimum Qualifications:** + Knowledge of Computer System Validation (CSV) + Knowledge of… more
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