- Eisai, Inc (Nutley, NJ)
- …experience in Pharmaceutical industry or similar.Familiarity with regulations governing software development and validation .Knowledge of Statistical Programming ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… 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)...the Manufacturing systems based on requirements, specifications, and developed software solutions Develop MES solutions including recipe, configuration and/or… more
- Merck & Co. (Rahway, NJ)
- …our team. The individual will play a critical role in the development and validation of flow cytometric assays that are deployed in support of clinical trials. The ... Research to Clinical by providing technical guidance on fit-for-purpose assay validation .Interface with scientists and physicians in early and late-stage clinical… more
- Merck & Co. (Durham, NC)
- …accordance with Computer Software Assurance (CSA)Lead the definition, SDLC documentation and validation of new master data and system parameters as a member of 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
- BioAgilytix (Durham, NC)
- …plans to implement automated solutions to support (GxP) validation and implementation, including protocol/throughput analysis; instrumentation specification; ... drafting user requirements; validation plans, test scripts and validation summary...for supporting the development and testing of new devices, software , components, and procedures; this includes but is not… more
- Lundbeck (Bothell, WA)
- …growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team.The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of… 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 ... overtime.Proficiency in the use and knowledge of PCs (Hardware & Software ) including Microsoft Windows platformInstrumentation troubleshooting skillsMust be able to… more
- Merck & Co. (Rahway, NJ)
- …including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and ... ISO 14971, EU MDR, Medical Electrical Equipment - EN 60601, Medical Device Software Standard - IEC 62304, ISO 11608 Needle-based injection system for medical… 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 ... Experience: Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)Experience providing technical and/or programming… 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 ... maximum lift of 20 poundsAbility to access and use a variety of computer software Ability to communicate information and ideas so others will understand, with the… more
- Merck & Co. (North Wales, PA)
- …vaccine clinical development projects. Accountability predominantly includes creation and validation of Case Report Tabulation (SDTM) study data deliverables Study ... knowledge of reporting processes Standard Operating Procedure (SOP) and software development life-cycle (SDLC)Experience ensuring consistency across protocols and… 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 ... process compliance. Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)US and/or worldwide drug or vaccine regulatory… more
- Eisai, Inc (Exton, PA)
- …to the Pilot Plant and LabsPartner with Site QA in the GMP validation of Lab automation.Document GMP documentation as per Exton SOPs.Partner with Infrastructure ... and supporting inventory ensure effective lifecycle, deployment, security, backup.Oversee software /patch testing and release process for lab software .Lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of experiments based on behavior science and customer feedback insights, including validation of experiment design and creation of UI/UX design to support ... design and prototyping tools such as Adobe Creative Suite, or other relevant software Demonstrated ability to drive innovation in design strategies and stay ahead of… more
- Eisai, Inc (Nutley, NJ)
- …to determine compatibility with existing infrastructure . Assess es new hardware and software as may be needed to implement proposed infrastructure design s and ... Data Protection Regulation (GDPR) for Cloud infrastructure qualification and validation . E xperience designing and implementing complex, global, multi-tenant, multi… more
- BioAgilytix (Durham, NC)
- …analyst on sample analysis projectsParticipates in assay development, validation , and sample analysisAdheres to provided method/directiveRuns assays ... maximum lift of 20 poundsAbility to access and use a variety of computer software Ability to communicate information and ideas so others will understand, with the… more
- BioAgilytix (Durham, NC)
- …assays according to GLP guidelinesFollow GLP guidelines for validation of assaysRun assays independentlyPrepare worksheets independentlyAnalyze and interpret ... maximum lift of 20 poundsAbility to access and use a variety of computer software Ability to communicate information and ideas so others will understand, with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development, analysis files development, data surveillance review, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as ... Sufficient programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc.- Strong analytical and problem-solving skills.- Some… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …specs review, SAP authoring, DB lock support topline results validation /interpretation, CSR co-authoring and eventual regulatory strategy development and submission. ... macros, analyses and reportsStrong knowledge and experience with sample size software like PASS, NQUERY etc.Strong communication (oral and written), presentation,… more
