- 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
- BioAgilytix (San Diego, CA)
- … Systems Analyst is responsible for providing support to projects related to validated computerized systems and the overall corporate infrastructure.Essential ... less than three (3) years' direct hands-on experience with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System … more
- 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
- Merck & Co. (Rahway, NJ)
- …BS/BA or an equivalent certification/experience in science, engineering, IT or related discipline with functional working experience in System ... will include:Project support for System Development, Maintenance, Enhancement and System Monitoring related initiatives.Serve as a liaison between the Global… more
- Repligen (San Diego, CA)
- …technical assistance and expertise to the CTI/Repligen sales force and customers related to the laboratory instrumentation its sells and supports. The laboratory ... by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and… more
- Merck & Co. (Rahway, NJ)
- …participate in Quality Notification (QN) reporting, investigations, and any related corrective action/preventive action (CAPA).- Facilitate equipment/ system ... and developmental supplies for sterile products, including critical program needs related to new products undergoing process development, new products undergoing… 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. (Rahway, NJ)
- …and external to GCS and serve s as the GCS spokesperson at clinical development related meetings (i .e., Clinical Trial Team s ) and product development related ... and other supply chain areas to address clinical supply related topics . - Responsible and accountable for establishing...and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for… 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 serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the Program CSPM designs strategic and operational ... chain areas to negotiate timelines ,- strategies and other related topics for all clinical supplies across all assigned...assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… 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 ... systems .Assist in the development of validation and qualification related policies, procedures, templates, formsProvides quality oversight on data integrity of… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …API requirements (no development experience required) in and out of Veeva CRM system .- Documentation: Document various system related documentations such as ... Qualifications (from an accredited college or university)Bachelor's Degree in Information Systems , Computer Science or business related discipline required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …room HVAC, refrigeration, pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor ... OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on… 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 ... other Site Business PartnersSupports small/moderate maintenance, production, and utility equipment related projects by planning path forward for least disruption to… 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 ... Animal Health Vaccines and related materials.Responsibilities include but are not limited to:Safety requirements are strongly adhered to; this individual must be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to provide statistical programming technical support related to R programming, R related system and technology. Develop and drive R programming, package, and ... as R programming SME and functional representative of R systems and infrastructure to identify system and...to resolutions of BDM departmental (internal and external) R related analysis and programming technical issues and difficulties. Lead… 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 or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Merck & Co. (Rahway, NJ)
- …colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and accountable for establishing the timelines for clinical ... 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… more
