- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation… more
- Aequor (Thousand Oaks, CA)
- …meet milestones on time. The qualified candidate will support verification, validation , and regulatory submissions of these devices. Work within a cross-functional ... functions.Responsibilities:Lead medium/small projects independently and work directly with Program Manager on large multi-year programs. Managing the overall program… more
- BioAgilytix (Durham, NC)
- The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information ... CFR Part 11, with a focus on data integrity and validation .Post-Implementation Optimization: Provide ongoing support and lead continuous improvement initiatives to… more
- BioAgilytix (San Diego, CA)
- …to the patients who need them.Essential ResponsibilitiesServe as Bioanalytical Project Manager (BPM)/Principal Investigator (PI) on a projectMay prepare and submit ... as lead scientist on assay dev projectServe as lead scientist on validation or qualificationPresent data to clientsIndependently write plans and reports for … more
- Genmab (Plainsboro, NJ)
- …integral part of the product roadmaps and planning and embed code validation services in POD processes.Security Awareness: Actively promotes information security and ... Managers and OwnersJob RequirementsEducationMinimum of a Bachelor's degree in computer science, information systems, engineering or related technical field or… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies. + Draft and review… more
- PCI Pharma Services (Philadelphia, PA)
- …By: Dennis Gerlach Approved By: Nancy Dorr **Summary of Objective:** Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities is ... resources for protocol execution. Collaborates with the site commercial Validation Manager for any validation ...experience + Statistical and Advanced Mathematical Skills + Advanced Computer Skills: Ability to perform the most complex … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation… more
- ThermoFisher Scientific (Greenville, NC)
- …Practices (GMP) Safety Standards, Office **Job Description** **Job Summary:** The Senior Manager of QA Validation will provide oversight and manage the ... and facilities meet quality standards and align with regulatory requirements. The Senior Manager will lead a team professionals, drive validation strategy, and… more
- Fujifilm (College Station, TX)
- …of innovation, representing a source of pride for the area. The Quality Assurance (QA) Manager , QA Validation , will be responsible for the review and approval of ... commissioning/qualification/ validation protocols, reports, and discrepancies. The Manager ...to sit for long periods to work on a computer . + Potential for exposure to chemicals, gases, fumes,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …If so, be empowered to take charge of your future at Takeda. Join us a Manager , Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda, we are ... performed by a vendor, as needed. + Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. + Ensure compliance with… more
- Carnival Cruise Line (Miami, FL)
- **Job Description** The Manager , Data Validation is responsible for the design and delivery of the MAST data validation process for all brands within the ... database build phase of the MAST Program + Oversee the end-to-end data validation process for core, reference and transactional data which includes. Receiving and… more
- Kelly Services (Deerfield, IL)
- …**Top 3-5 Must Have Non-negotiable Skills Required** 1. Experience working in Computer System Validation (CSV) Documentation; Functional and Technical 2. ... Length, Rounds, Team involved) 2 rounds 1st with the manager 2nd with a BA on the team Project-...key tasks, demonstrate solid knowledge of validated systems and computer system validation , require moderate direction, give… more
- Fujifilm (College Station, TX)
- …of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- PCI Pharma Services (Rockford, IL)
- …pioneer and shape the future of PCI. **Summary of Objective:** The Validation Engineer is responsible for the qualification/ validation of pharmaceutical ... testing, and packaging of medical devices. Core functions include management of validation projects, generation and execution of validation protocols, evaluation… more
- Editas Medicine (Cambridge, MA)
- …ideal candidate should have experience with Veeva QMS, Blue Mountain Regulatory Asset Manager (BMRAM), and Kneat (or similar paperless validation solutions). In ... + Experience with Facility/utility qualification activities. + Should have experience with Computer Systems Validation for systems like Veeva, LIMS, Learning… more
- System One (Bellevue, WA)
- …Design Basis Accident (DBA) Without Radionuclide Release + Nuclear safety analysis computer code assessment, verification and validation The Safety Verification ... (EM) following the guidance in NRC's RG1.203. + Perform and coordinate safety computer code verification and validation test programs, including SETs and IETs,… more
- Novo Nordisk (Clayton, NC)
- …us make what matters. The Position Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects. ... Relationships Senior Project Manager , Site Capacity &..., Site Capacity & Upfit. Essential Functions + Provide validation & technical support through the preparation, execution, data… more
- Abbott (Austin, TX)
- …oversight on product, process, and equipment related changes and implementations ( validation & change control). Specifically, + Provide quality support and oversight ... (approval) of process and equipment validation and change control records and activities, + Ensure...+ Works independently with objectives given by the Quality Manager . + Plan and coordinate own work according to… more
- Catalent Pharma Solutions (Kansas City, MO)
- … reviews and re- validation activities. This position reports to the Engineering Manager . **This is a full-time role position: Monday - Friday, Days. 1st Shift ... ** Validation Process Engineer** **Position Summary** Catalent Pharma Solutions...good communication and problem-solving skills highly desired. + Working Computer knowledge of Microsoft Outlook, Word, Excel, Internet Explorer… more
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