- Eisai, Inc (NJ)
- …eTMF system related inspection readiness activities.Must have good understanding of computer systems validation and related processes. Knowledge and ... of eTMF including, but not limited to version releases, system updates, validation or user acceptance testing,...Salary Transparency Language:The base salary range for the Senior Manager , eTMF System is from :114,600-150,500Under current… more
- Aequor (Piscataway, NJ)
- …formatting/document-level publishing (eg, Acrobat, DXC Toolbox, authoring templates). Understanding of computer system validation principles and change ... Two new Regulatory Manager requisitions are about to go live in...system business owners, IT, and QA to support system . implementations and updates including execution of validation… more
- Aequor (San Diego, CA)
- …formatting/document-level publishing (eg, Acrobat, DXC Toolbox, authoring templates). Understanding of computer system validation principles and change ... The Manager , Regulatory Publishing is responsible for publishing, QC,...system business owners, IT, and QA to support system . implementations and updates including execution of validation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of BMS hardware and software Work with PM to support the commission the system , ensuring all devices and systems are correctly connected and functional Work ... with PM to conduct system testing and validation to ensure proper...systems At the direction of the functional area manager (FAM), develop and maintain Key Performance Indicators (KPI)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. ... of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project … more
- BioAgilytix (San Diego, CA)
- …proficiency with data management, analysis, and statistics, etc.Understands and applies computer validation principles, computer literate with knowledge ... GLP bioanalytical experience, strong understanding of LC-MS/MS method development and validation , and demonstrated ability to lead large, regulated teams in… more
- Eisai, Inc (Nutley, NJ)
- …software applications development/support in the pharmaceutical or related industries, and system validation methodologies.Excellent technical skills in SAS ... with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively… more
- Catalent Pharma Solutions (Somerset, NJ)
- **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ **JOB DESCRIPTION** : ... and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leverage existing systems for the assurance of GMP… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Manager , Computer Systems Validation **City:** Harmans **State** : MD **JOB DESCRIPTION** : + Serve as the QA-CSV liaison with the ... and Validation organizations to support SaaS enterprise computer systems validation of Gene...Guidance's on electronic data integrity. + Support GMP manufacturing Computer System Validation including Pall… more
- CACI International (Houston, TX)
- …integrated Verification and Validation (V&V) of the on-board, autonomous Vehicle Systems Manager (VSM) and Autonomous Systems Management Architecture ... Lunar Gateway Autonomous Control System Verification and Validation (V&V) Software Systems Engineer Job Category:...USG facilities. + BS in Electrical, Mechanical, Aerospace, Software, Computer or Systems Engineering, Computer … more
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems ... functional areas across the organization to maintain and improve computer system validation processes to...experience working in a cGMP regulated industry specific to computer systems validation + … more
- System One (Bellevue, WA)
- …experience in nuclear safety software verification and validation activities and system transient analysis computer code benchmark. * Familiarity with EMDAP ... Design Basis Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety… more
- Astrix Technology (Atlanta, GA)
- …Bachelor's in chemistry or related field.Must have 2 years' experience with computer systems validation within the pharmaceutical or chemical ... ** Validation Manager ** **_Duties:_** Supervise technical teams...proposals. Lead Validation Projects and manage the validation lifecycle of computer systems ,… more
- Actalent (St. Louis, MO)
- …facilities, utilities, processes (such as cleaning and sterilization), computer systems , and test methods, applying the validation lifecycle approach in ... Job Title: QA Manager - ValidationJob Description This role serves as...Expertise in two or more of the following areas: Validation of computerized systems , software, automation, analytical… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …met. + Develops cGMP operating procedures that relate to process, information systems , and equipment validation /qualification. + Ensures compliance with SOPs ... to implementation for routine use. This includes donor center processes and information systems . + Analyze validation data to ensure acceptance criteria are met.… more
- NVIDIA (Santa Clara, CA)
- …work, to amplify human creativity and intelligence. NVIDIA is looking for motivated System /Board Design Validation Engineers to use your creativity to work on ... the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU...the highly inventive team. What you'll be doing: + System /board level debug and validation of NVIDIA… more
- Novo Nordisk (Bloomington, IN)
- … Science, or applicable technical degree required OR 10+ years of experience in computer system validation or quality related discipline in lieu of ... matters. The Position Primary purpose is to provide the validation of IT Systems for system...degree. + Mastery in validation of computer systems , operation… more
- Novo Nordisk (Bloomington, IN)
- … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... validation + Understand other validation technical disciplines, such as equipment validation , computer system validation , and process … more
- Pfizer (Sanford, NC)
- … skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms ... documentation including but not limited to, change controls, cleaning/process/equipment/laboratory validation , data records, SOPs, automation, engineering and maintenance document… more
