- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- BioAgilytix (San Diego, CA)
- …less than three (3) years' direct hands-on experience with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System ... The Laboratory Systems Analyst is responsible for providing support to...etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data… more
- Eisai, Inc (Boston, MA)
- …of contact between Eisai and formulary decision-makers within identified Health Systems representing Eisai's product portfolio.The Health System Account ... for creating access to Eisai's product portfolio in identified Health Systems while building a strong corporate presence with formulary decision-makers and… more
- Segula Technologies (Wichita, KS)
- …challenges while fostering innovation and sustainability. Job Description As a Mechanical Systems Design Engineer you will support the new design and modifications ... of aircraft structures and/or systems and are responsible for the creation of quality...efforts for both metallic and non-metallic parts along with system installations (electrical, hydraulic, fuel) while working in close… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Repligen (San Diego, CA)
- …by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and ... and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system … more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… more
- Merck & Co. (Durham, NC)
- …and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment ... specification data within the computerized calibration and maintenance management system .Troubleshoots equipment and performs necessary repairs. Utilizes various instruments… more
- Twist BioScience (South San Francisco, CA)
- …RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San ... product lines and deep understanding of integration to eCommerce and ERP systems to ensure scalable, robust, and flexible cross-functional solutions that support our… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Omaha, NE)
- …be responsible for installing, maintaining, troubleshooting, and repairing equipment, utility systems , and facility needed for the storage, packaging and shipping of ... troubleshooting and maintaining equipment, performing root cause analysis on system failures and substandard equipment performance, using standard problem-solving… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Merck & Co. (Rahway, NJ)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies .… more
- NY CREATES (Albany, NY)
- … system operations, preventative maintenance, troubleshooting techniques, typical system failures and corrections. Provide recommendations on equipment/ systems ... innovation and commercialization. Job Description: Job Description for Facilities Systems Control Integrator JOB SUMMARY Operation, maintenance, testing and repair… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Eisai, Inc (San Jose, CA)
- …pathway).Engage and influence key customers (including local and regional hospital systems ) to sustain a strong organizational presence in the Alzheimer's ... key stakeholders that influence decision-making within local markets and healthcare systems ).Experience working with healthcare delivery systems (including buy &… more
- Merck & Co. (Rahway, NJ)
- …assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report ... and clinical customer relationship management.-Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand planning… more
- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... or finished pharmaceutical environmentExperience in automation and manufacturing execution systems (MES), process modeling and process improvement.Mechanical functionality and… 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, ... self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, MES, SAP, PI Historian)… more
