- 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
- 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
- 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
- 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
- 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 (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
- 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
- zobility (Allen Park, MI)
- Position Description: The Hardware in the Loop (HiL) Software Validation Engineer supports the SW product development and system integration processes by developing ... utilizing software testing or quality assurance methodologies 2+ Years of experience in validation support of dSPACE or NI HIL simulators 2+ Years of experience in… 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
- 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
- Catalent (St. Petersburg, FL)
- …batches, registration/stability batches, and technical support of process validation batches. Additional responsibilities may include support of ... requirements include reading of written documents and frequent use of a computer monitor. Vision requirements include ability to differentiate color, have 20/30… more
- Merck & Co. (Rahway, NJ)
- …entire product lifecycle.Develop effective study and report programming and validation utilizing global and Therapeutic Areas standards and following departmental ... in departmental strategic initiative teams.Requirements:Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, Computer… more
- Merck & Co. (North Wales, PA)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... strategic initiative teams Education and Minimum Requirement :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related… more
- BioAgilytix (Durham, NC)
- …their expertise in molecular biology, further developing their skillset in the development and validation of PCR assays. If you are a person who is energized by ... moves) objects including laboratory equipment, laboratory supplies, and laptop computer with a maximum lift of 20 poundsAbility to...20 poundsAbility to access and use a variety of computer software Ability to communicate information and ideas so… more
- Merck & Co. (North Wales, PA)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... on departmental strategic initiative teams Educational Qualifications :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or… more
- Merck & Co. (Durham, NC)
- …and maintenance of equipment/utility systems.Assist with execution of calibration, automation, validation and additional testing, as requiredWork within a team to ... floor level. Walking, bending, crawling and stooping are required.Proficiency in computer systems and applications including but not limited to:- Microsoft Office… more
