- BioAgilytix (San Diego, CA)
- …reviews of validated computer systemsPerforms administrative tasks for specialized scientific applications and other corporate systems ; this may include but ... field Not less than five (5) years' experience supporting scientific and enterprise systems , including but not limited to: application servers, Active Directory,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to identify/remediate gaps in processes.Operational experience with electronic quality systems is required.Proficient with using Microsoft Office applications ... 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… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications .Current Employees apply HERE… more
- Merck & Co. (Rahway, NJ)
- …Qualifications, Skills, and Experience Experience in using the following systems and applications : Programmable Logic Controllers (PLC), Allen ... through statistical techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop and-maintain-Site… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing ... Security Operations - Americas. Will work closely with IT operations staff, application development teams, system managers, and line of business representatives.… 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. (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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the successful integration of Veeva CRM and Omnichannel Marketing features with other systems and applications such as C360, data warehouse, marketing cloud, ... for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to… more
- Novo Nordisk Inc. (Durham, NC)
- …Proven expertise in Windows based operating systems and associated applications required Proven expertise in system interfacing and integration required ... years of Engineering experience in process-based manufacturing, utility, &/or packaging systems required Knowledgeable in the following applications or… more
- Eisai, Inc (Nutley, NJ)
- …and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be ... and system validation methodologies.Excellent technical skills in SAS system , JReview and application development.Provide technical guidance to the… 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
- 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
- Insmed Incorporated (San Diego, CA)
- …role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national ... Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the COE Develop and leverages relationships with HQ SMEs, process management, and system management to influence process and system development in a manner ... cross-functional projects in the development and/or implementation of processes and programs System Management Acts as SME for the current deviation management IT … more
- Merck & Co. (Rahway, NJ)
- …is preferred):BS/ BA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 20 ... development.MS/ MA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems across the organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet ... defining and driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy,… 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
- 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
