- Daiichi Sankyo, Inc. (Basking Ridge, 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
- BioAgilytix (Durham, NC)
- …and file permission settings as it pertains to data integrity and computer system validation .Detail oriented and highly organizedExcellent oral and written ... project plans to implement automated solutions to support (GxP) validation and implementation, including protocol/throughput analysis; instrumentation specification; drafting… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business for guidance ... and consultancy on system validation . Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions ... implementation teams (including external vendors) in the design, development, implementation, validation , roll-out, training and support of global and regional DS… more
- Catalent (Philadelphia, PA)
- …Quality operating procedures as needed. Provides leadership for Data Integrity and Computer System Validation documentation review and approval for instruments, ... Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. Management responsibilities include professional development, performance… more
- Merck & Co. (Durham, NC)
- …3 yrs of aseptic processing/sterile manufacturing experience.-Emerson DeltaV, PLC, computer validation and systems life-cycle development methodology experience ... required.Preferred Experience and Skills: Experience working with Information Technology teams.Experience with regulatory audits and working knowledge of data integrity principles. -Understanding of Lean Manufacturing /Six Sigma methodology.Strong leadership,… more
- Merck & Co. (Rahway, NJ)
- …as well as the vendor to ensure that the computer system operation and computer system validation is completed and maintained, and that the field devices in ... future changes to the system such as system expansion projects from either a computer system perspective or from a field device perspective as well as also leading… more
- Eisai, Inc (Nutley, NJ)
- …compliance, is essential.Experience in managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP. Leadership ... College diploma or university degree in the field of computer science, information science, management information systems, or business administration.Minimum… more
- Sunrise System Inc (Summit, NJ)
- …knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Advanced ... simultaneously. Strong presentation development and delivery skills. Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint,… more
- Sunrise Systems inc (Warren, NJ)
- Job Title: Validation Qualification Specialist Job ID: 24-02588 Location: Warren, NJ, 07059 Duration: 12 Months contract on W2 This role is 100% Onsite Work ... Mon - Fri, Business Hours 1. PURPOSE AND SCOPE OF POSITION: The Validation Engineer supports the successful implementation of laboratory equipment and systems at… more
- Genmab (Allentown, NJ)
- …implementing agile and DevOps methodologies for efficient delivery. If product requires computer system validation , be accountable for the initial GxP ... Research and Development to manage dependencies. Requirements: Bachelor's degree in Computer Science, Engineering, Lifesciences. MBA or Master's degree in strategy,… more
- American Honda Motor Co Inc (Greensboro, NC)
- General Summary:With minimal supervision, the Validation Team member is responsible for facilitating and coordinating activities to support FAA conformity, domestic ... provide communication within the company in support of Conformity and Validation projectso Review certification documentation to ensure accuracy and compliance with… more
- American Honda Motor Co Inc (Greensboro, NC)
- Job PurposeWith minimal supervision, the Validation Team member is responsible for facilitating and coordinating activities to support FAA conformity, domestic ... provide communication within the company in support of Conformity and Validation projectsReview certification documentation to ensure accuracy and compliance with… more
- Careerbuilder-US (Kirkland, WA)
- …6 months contract ( Go longer as per business need) About the Role The Validation Support Technician 3 will be responsible for providing support to Validation ... or relevant experience (5+ years is preferred) Experience within a computer hardware and/or lab environment Python/PowerShell Scripting experience Working knowledge… more
- MAHLE, Inc (Lockport, NY)
- …parameters including measurements of temperature, pressure and flow.Interface with computer based electronic test systems.Understand and execute tests efficiently ... and correctly.Observes consistency in test data, interprets results and report irregularities to test engineer.Diagnosis and resolve test component or bench issues, perform basic repairs and maintenance.Ability to cross training in various Test Laboratory… 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)...Bachelor's degree or equivalent experience. Experience: 5&plus years in computer or science-based field Direct experience in Emerson Syncade… more
- Rose International (Peoria, IL)
- The client, seeks a skilled Systems Engineer with a background in Electrical or Computer Engineering, holding a minimum of a 4-year degree. They require at least 3 ... years of experience in system integration and validation , ideally within a complex operational environment. Key technical...degree is required (4 year degree at a minimum) Electrical/ computer preferred, but open based upon experience Minimum 3… more
- Catalent (St. Petersburg, FL)
- …Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; ... c) all product process validation and cleaning validation documents; d) all...requirements include reading of written documents and use of computer monitor screen frequently. Why You Should Join Catalent… more
- Aequor (Thousand Oaks, CA)
- …equipment/system design, specification and supporting the construction, startup, and validation of equipment. Support Lean Transformation and Excellence in ... any equipment modifications and acquisition. Ensure safety during commissioning, validation , maintenance and manufacturing activities. Support Manufacturing and QA… more
- Merck & Co. (Durham, NC)
- …Life Cycle upkeep of new and existing MES environments in accordance with Computer Software Assurance (CSA)Lead the definition, SDLC documentation and validation ... a team responsible for new products/MBR's.Lead the definition, SDLC documentation and validation of master data and system parameters changes required for MES system… more
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