- 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
- 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)
- …Research areas preferred.Start date: -As soon as possible.Job Description: Seeking a full- time Business System Associate for the Labeling Operations area within ... Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit...believe we would pay for this role at the time of this posting. An employee's position within the… more
- Merck & Co. (Rahway, NJ)
- …is responsible for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. - This role ensures HVAC ... systems comply with regulatory standards (eg, FDA, cGMP), maintain...analytics.Establish and monitor key performance indicators (KPIs) for HVAC system reliability, energy efficiency, and compliance.Lead root cause analysis… more
- Merck & Co. (Durham, NC)
- …We're looking for a dedicated professional to ensure top-notch quality, on- time delivery, and seamless operations in a dynamic GMP manufacturing environment.Primary ... ability to meet customer expectations in term of quality/quantity and on- time delivery as appropriate.Oversee and maintain schedule adherence and unplanned… more
- Novo Nordisk Inc. (Boston, MA)
- …working with internal stakeholders regarding all relevant parties assigned to health system Estimate the level of investment, time , human resources, and ... Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders.… 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
- 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...define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling… 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this ... for performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing security… 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 (Vacaville, CA)
- …as the team ramps up to deploy numerous new PAT systems while supporting existing systems . At least 75% of the candidate's time will be spent gowned into the ... analytical systems , data analysis, and troubleshooting Knowledge of SAP system is a plus Must have excellent interpersonal, communication, and teamwork skills… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... improve performance.Apply technical skills and ingenuity to correct equipment and system problems that result in downtime or consume excessive maintenance resources… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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...11, Annex 11); possess a strong understanding of IT system architecture and cloud-based environments.Manage third-party vendors, system… more
- Merck & Co. (Durham, NC)
- …that's committed to delivering a compliant, reliable supply to customers and patients on time , every time , across the globe. The Senior Maintenance Technician is ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- Merck & Co. (Rahway, NJ)
- …performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating ... ensure practices are accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during documentation… 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 ... background Required Experience and Skills: Strong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP… more
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