- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems ... or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such...and Non-GxP computer systems .Create and review various validation documentation such as Validation Plans, Protocols… more
- ICONMA (Columbus, OH)
- Responsible for the design, install, commission, validation , and start-up of manufacturing process systems for ingredient preparation, liquid processing, CIP, ... Familiarity with plant control software, including PLC / HMI and SCADA systems . Familiarity with liquid aseptic processing/filling in the food industry. Experience… more
- 804 Technology (North Richland Hills, TX)
- …processes including requirements definition, requirements allocation, requirements validation , requirements verification, integration, embedded software, electronic ... Safety, Security, and Certification organizations. Ensure timely delivery of systems requirements, integrated validation /verification activities, and issue… more
- Butler Aerospace and Defense (Richland Hills, TX)
- …processes including requirements definition, requirements allocation, requirements validation , requirements verification, integration, embedded software, electronic ... Safety, Security, and Certification organizations. -Ensure timely delivery of systems requirements, integrated validation /verification activities, and issue… more
- Metasys Technologies, Inc. (Columbus, OH)
- …Ensure pricing, promotion, and coupon data flows correctly to integrated systems . Use standard software testing methodologies: test planning, scope identification, ... with provided company equipment. Key Skills: Web, mobile, and data validation experience. Metasys Technologies is an equal opportunity employer. All applicants… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …existing equipment, processes, and instrumentation in accordance with science and risk-based validation (SRV). This role will provide input to project team members ... of Brownfield projects including: installations, modifications, and ugrades to existing systems & equipment. This position can be considered for Commissioning… more
- Merck & Co. (Durham, NC)
- …and disciplines on scheduling repairs and maintenance of clean utility systems .Assists with execution of automation, validation and additional testing, ... skids, chromatography columns).Support Equipment (eg washers, autoclaves, tube welders/sealers).Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers… more
- Aequor (Bothell, WA)
- …another MES system will be considered. Experience with writing and executing validation protocols. PURPOSE AND SCOPE OF POSITION (Position Summary):The MES Recipe ... Engineer and Validation Specialist role will deliver electronic batch record (EBR)...development and implementation of new capabilities across the Manufacturing systems based on requirements, specifications, and developed software solutions… more
- Aequor (Thousand Oaks, CA)
- …lead implementation of engineering based improvements or upgrades to the equipment systems . This may include development of reason for improvement and identification ... equipment/system design, specification and supporting the construction, startup, and validation of equipment. Support Lean Transformation and Excellence in… more
- Rose International (Peoria, IL)
- …Systems Engineer Responsibilities: The team is accountable for integrating multiple systems together and performing validation for the autonomous truck ... The client, seeks a skilled Systems Engineer with a background in Electrical or...least 3 years of experience in system integration and validation , ideally within a complex operational environment. Key technical… more
- Aequor (Thousand Oaks, CA)
- …minimizing project cost and schedule impact (risk-based approach). Oversee development of validation protocols in line with CQP, Automation Systems Delivery ... using risk-based approaches Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections Participate in internal… more
- Catalent (St. Petersburg, FL)
- …The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.The QA Product Manager ... Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems ; b) process improvement projects and Product Development Projects; c)… more
- Aequor (Devers, TX)
- …Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations Reviews and approves Quality, Quality Control, ... Validation and Automation related documents Review and approves Standard...regulations and guidance and GAMP 5. Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise,… more
- Careerbuilder-US (Foster City, CA)
- …quality data/ analytics and reporting, quality documentation and training, quality technology and systems validation , and other related activities. * May lead or ... support projects. * Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements. REQUIREMENTS: Education & Experience * PharmD/PhD with 2+ years' experience. * MA/MS/MBA with 8+ years' relevant… more
- Merck & Co. (Rahway, NJ)
- …equipment reliability/performance.- Partner with cross-functional teams to implement sterile validation program. Contribute to the planning, design, and execution of ... validation procedures and studies. Actively participate to achieve program...(verbal and written).-Preferred Experience and Skills:-Familiarity with Capital Project systems (administration and execution) as well as Computerized Maintenance… more
- Aequor (Swiftwater, MN)
- …definition, functional design, master data configuration and data migration, system validation , SOP revisions and development of end-user training. - Provide ... - Support business and Global IS LIMS Administrator in the creation, validation and maintenance of reports, calculations, queries - Provide first level diagnostic… more
- Merck & Co. (Durham, NC)
- …Automation (MES Engineer) is responsible for supporting the Manufacturing Execution Systems (MES) that directly support the Maurice R. Hilleman Vaccine Manufacturing ... in accordance with Computer Software Assurance (CSA)Lead the definition, SDLC documentation and validation of new master data and system parameters as a member of a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …coding & programming, ideally 'from scratch' Assists with troubleshooting, testing, validation , deployment and on-going maintenance of Automation Systems ... with the design, procurement, construction, installation, engineering start-up, documentation and validation activities of new and modified control systems … more
- MAHLE, Inc (Lockport, NY)
- …OEMs. ESSENTIAL DUTIES AND RESPONSIBILITIESTest set up of Automotive HVAC systems , modules, heat exchangers or sub-components such as blowers and actuators ... temperature, pressure and flow.Interface with computer based electronic test systems .Understand and execute tests efficiently and correctly.Observes consistency in… more
- BioAgilytix (Durham, NC)
- …responsible for leading the programming and implementation of automation laboratory systems . This role requires a deep understanding of laboratory automation ... project plans to implement automated solutions to support (GxP) validation and implementation, including protocol/throughput analysis; instrumentation specification; drafting… more