- Aequor (Bothell, WA)
- Job Description: Job title: Computer System Validation EngineerLocation: Bothell, WA* HybridTop Skills: Strong knowledge on MES systems (ie Emerson Syncade) and ... part 11, and good documentation practices. PURPOSE AND SCOPE OF POSITION:The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner ... areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for… more
- BioAgilytix (Boston, MA)
- …as 21 CFR Part 11, Annex 11, Annex 15, CLIA and GAMPs- Perform the quality review of equipment SOPs, policies and validation master plans for equipment ... (2)years' experience in pharmaceutical/GxP/regulated environment- Direct hands-on experience with computer systems validation and/or equipment qualifications- Direct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions to ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services… more
- Tris Pharma (Monmouth Junction, NJ)
- …in analytical method development, physical characterization, formulation support, interim validation , pilot release testing and stability testing activities for all ... in-house analytical capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current… more
- Aequor (Bothell, WA)
- …Top Skills: BS in Scientific Discipline, preferably Microbiology Computer proficiency Regulated industry experience Strong communication skills Demonstrated ... Onsite Schedule: Wed-Sat 0600-1630 The primary focus of the Quality Control Associate I role will be to support...work from multiple projects. Strong analytical and communication skills. Computer proficiency as well as the ability to master… more
- Merck & Co. (North Wales, PA)
- …quality deliverables.Effective analysis and report programming development and validation , utilizing global and therapeutic area (TA) standards and following ... the safety and efficacy claims of potential medical breakthroughs.Review the quality and reliability of clinical studies using deep scientific knowledge, statistical… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... SOP development; maintenance development & training & management of cost, quality & schedule within area of responsibility. Establish & maintain positive… more
- Merck & Co. (Durham, NC)
- …programming Emerson DeltaV or PLCs (ladder logic, HMIs, or SCADA) required. Computer validation and systems life-cycle development methodology experience ... embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- -Supports a large spectrum of sophisticated… more
- Eisai, Inc (Nutley, NJ)
- …such as Scrum. Experience in managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies and /or ... and rollout of relevant technologies and platforms. Accountable for overall quality and delivery of Revenue Management (Contracting, Medicaid, Govt. Pricing,… more
- Merck & Co. (Durham, NC)
- …an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.Responsible for ... and maintenance of clean utility systemsAssists with execution of automation, validation and additional testing, as requiredResponsible for written documentation of… more
- Aequor (Waltham, MA)
- …and regulations, particularly within GxP environments. Oversee the implementation and validation of GxP and SAS environments, ensuring they meet the company's ... SLAs are met. Manage vendor relationships, ensuring cost-effective and high- quality service delivery. Qualifications: Bachelor's degree in Information Technology, … more
- Merck & Co. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.- - Responsible ... maintenance of clean utility systems Assists with execution of automation, validation and additional testing, as required Responsible for written documentation of… more
- Lilly (Lebanon, IN)
- … Systems/Data Integrity Quality Assurance role is responsible for oversite of computer system validation at the Eli Lilly Lebanon API Manufacturing facility. ... technology-related field + 1+ year of experience in Automation/QC Labs/IT, Quality , or computer system validation in the pharmaceutical industry **Additional… more
- Catalent Pharma Solutions (Chelsea, MA)
- …kind for DPI in North America. Catalent Pharma Solutions is hiring a Computer System Validation (CSV)/ Qualification Engineer is responsible for managing, ... developing, and implementing the Computer System Validation program and equipment qualification...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… 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** + 40 hours ... with 21CFR Part 11 compliance. + Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems. +… more
- J&J Family of Companies (Columbus, OH)
- Staff Computer System Validation (CSV) Engineer - 2406213015W **Description** Johnson & Johnson Abiomed is recruiting for a **Staff Computer System ... consistent CSV execution and provide SME support at Abiomed. + Develop and execute validation plans for new and existing GxP computer systems and digital… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... business expectations. **Key Responsibilities:** + Define and maintain a global Computer System Validation (CSV) methodology and policies/procedures in… more
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