- Legend Biotech USA, Inc. (Raritan, NJ)
- …and provide repairs to equipment, instruments, instrumentation systems, electrical systems, controls , motors with voltages up to 600 voltsOperate, monitor, and ... maintain switchgearWorking knowledge of building automation systems, including PLC's, HMI's, sensors, and other componentsFamiliarity working with validated and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support ... preferred.Prior experience leading large multilevel teams.A history of developing and building cohesive, high performing teams with a strong sense of mission,… more
- Merck & Co. (Rahway, NJ)
- … control .Identify and follow through on opportunities to improve building flexibility, efficiency, compliance, and safety.Author lessons learnt and summary ... facility readiness for batch processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of systems at the CAR-T Raritan SiteReview and approve change controls , SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ... and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. Our focus on innovation ensures we're constantly building future capabilities. We're responsible for regulating accounting, upholding workplace ... and application level. Some responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly… more
- Eisai, Inc (Nutley, NJ)
- …new technologies/ procedures across clinical quality programs Direct skill- building interventions for CQA staff through cross-functional/ external partnerships ... carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... to lay the groundwork for future predictive models focused on quality control , lab maintenance, and operational forecasting.Assess core lab and operational data for… more
- Twist BioScience (South San Francisco, CA)
- …with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.About Twist ... adoption, effective GxP training programs, and adherence to change control procedures for custom software releases.QualificationsBachelor's degree in Computer… more
- Eisai, Inc (Exton, PA)
- …of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific team focused on the technology transfer, scale-up, and ... Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of… more
- Formation Bio (New York, NY)
- …of our Data Platform. This role is ideal for someone passionate about building scalable infrastructure at the intersection of data engineering and applied AI. You'll ... sense of complex documents like clinical protocols and drug labels or building robust data pipelines that power operational and scientific decision-making, your work… more
- AUROBINDO (Durham, NC)
- …expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an ... team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture,… more
- AUROBINDO (Durham, NC)
- …expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations...position is also required to work closely with Quality Control to make sure that the process flows smoothly… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... stakeholders Collaborate with cross-functional teams to support the design and building of data pipelines for cleaning, transforming, and combining datasets from… more
- Merck & Co. (Austin, TX)
- …and REST APIs.Participate in test planning, safety validation, change control , and rollback design.Document technical implementations, integration patterns, and ... Defender, Sentinel, or ServiceNowProficient in scripting (Python, PowerShell) and building workflows using REST APIsStrong understanding of cybersecurity fundamentals… more
- Merck & Co. (Durham, NC)
- …existing infrastructure and expertise, identify gaps and develop plans for building the organization to meet business needs).Ensure uninterrupted ability to meet ... problem-solving skills.- Strong risk-based decision-making skills.A positive, collaborative, consensus building approach to management and interpersonal relationships that focuses… more
- Merck & Co. (Rahway, NJ)
- …creating optimal development, commercialization, and drug/delivery device supply strategies- Building our leadership and functional capability to keep pace ... Skills:Business, Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure ... organization to ensure translation of changes from concept to implementation, building long term implementation and support plans.Ability to work independently and… more
- Merck & Co. (Durham, NC)
- …and safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs)Compliance with current good manufacturing procedures(cGMP), safety and ... RequiredFlexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequired Skills: Building Automation Systems, Computerized Maintenance Management Systems (CMMS), Electrical… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional and cross-regional users and stakeholders while building strong working relationships.Effective communication skills (verbal and ... as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements and… more
- Merck & Co. (Rahway, NJ)
- …for pipeline biologics, we are focused on innovating and building next-generation biomanufacturing technologies. This includes investments in continuous ... in media/solution development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics (transcriptomics,… more
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