- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification, process ... data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment, utilities, and… more
- BioAgilytix (San Diego, CA)
- … systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation , following GxP regulations and GAMP guidelinesAdvanced ... IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation ... Adaptability, Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data Analysis, Diversity and… more
- Merck & Co. (Rahway, NJ)
- …medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to positively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory… more
- Merck & Co. (Rahway, NJ)
- … Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation ... plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP… more
- Merck & Co. (Durham, NC)
- …Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing for the BCG Product. The position will focus on ... for commercial production.- The selected candidate will participate in equipment validation , process validation , and GMP laboratory readiness.- The Quality… more
- Twist BioScience (South San Francisco, CA)
- …Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for… more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Repligen (Rancho Dominguez, CA)
- …device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP or ISO ... Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation , and… 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
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- Merck & Co. (Rahway, NJ)
- …Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, analyze data, and ... in the purification of biological molecules, including chromatography and filtration systems .Technology Transfer Experience: Proven track record in tech transfer or… more
- Genmab (NJ)
- …according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and ... listings etc.Review assay validation reports, as applicablePerform exploratory analysis, ad hoc analyses,...stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Formation Bio (New York, NY)
- …therapeutics while ensuring these capabilities evolve into robust, production-ready systems .Responsibilities Lead the Platform Science arm of Data Science, building ... product teams to transition proof-of-concept models into scalable, production-ready systems Define technical execution strategy for clinical outcome prediction,… more
- Aequor (Devers, TX)
- …pricing, vendor IDs, UPOM, AUOM, etc. Vendor Setup: Manage vendor setup from one ERP System to another ERP Systems (ie, Oracle to SAP). Dual Sourcing Setup: When ... Sourcing initiatives and the implementation of a new ERP system (SAP) at multiple Client sites. This role will...approve all necessary UAT test scripts. DCT Verification and Validation : Approve Site Procurement Data Load Files in support… more
- Novo Nordisk Inc. (Durham, NC)
- … systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project Management, Batch Reporting, ... practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor ... to identify root cause and appropriate corrective actions for equipment system problemsHelps support the optimization of calibration frequencies through a… more
