- 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...GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for ... around rare diseases and immune disorders. Job Summary: The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that… more
- Repligen (Rancho Dominguez, CA)
- …device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP ... manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and facility upgrades. Conceives, plans, and executes projects or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for ... instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer I will work alongside Process Associates and … more
- Merck & Co. (Rahway, NJ)
- …Change Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems , Project Management, Regulatory Compliance, ... and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. -...Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain… more
- Novo Nordisk Inc. (Durham, NC)
- …Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the ... process improvements. Develop plans to improve the performance of a process or set of systems , using green belt concepts. Develop & manage project budget for… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... requested.Preferred Experience and Skills:Candidate must be familiar with IT system and business process support, preferably in...process minded with a short learning curve for systems and processes to drive results based on specified… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Vault RIM)Work with GRA stakeholders to define appropriate KPIs/metrics to track process compliance, performance and adherenceWork with the data/ systems SMEs to ... around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the...a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready? The Position Responsible for leading process , reporting and compliance related activities for US Talent Acquisition. Responsible ... of US regulations and laws are upheld under globalized process changes Manages the overall US compliance to ensure...way Prior experience with data extraction from Talent Acquisition systems and tools required The base compensation range for… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... and provides leadership to complex maintenance planning including shutdownMaintains process equipment by developing/performing PM's, installing new equipment, documenting… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions ... installation, engineering start-up, and validation activities of new equipment and systems , including documentation of IQ/OQ protocols, test executions, and summary… more
- Repligen (Boston, MA)
- …and driven Bioprocessing Sales Specialist to join our team, focusing on Process Analytics Products for downstream Process Analytical Technology (PAT) using ... and Business Development: Drive sales and business development activities for Process Analytics Products within the Northeast Territory. Develop and execute… more
- Merck & Co. (Durham, NC)
- …Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- Merck & Co. (Rahway, NJ)
- …Engineering Standards, Environmental Health and Safety (EHS) Management, HVAC Systems , Identifying Risks, Maintenance Processes, Management Process , Programmable ... data modeling-to enable better business decisions.-Through analysis of equipment history, process data, operating procedures and Failure Modes Effect Analysis and… more
- Merck & Co. (Rahway, NJ)
- … Engineering, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Management System , Quality Management, Quality Management ... products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the… more
- Merck & Co. (Rahway, NJ)
- …Management Process , Manufacturing Processes, Manufacturing Quality Control, Process Improvements, Quality Assurance (QA), Quality Assurance Systems , ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… more
- Merck & Co. (Durham, NC)
- …projects that help improve the business by streamlining workMaintains process equipment by developing/performing PM's, installing new equipment, documenting work ... using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical Services Engineer.Routinely provides technical… more
- Aequor (Vacaville, CA)
- …In this role, you will be primarily accountable for ensuring your assigned Process Analytical Technology (PAT) Systems deployed on the manufacturing floor are ... analytical systems , data analysis, and troubleshooting Knowledge of SAP system is a plus Must have excellent interpersonal, communication, and teamwork skills… more
- Twist BioScience (South San Francisco, CA)
- …and data synchronization.Enable and enhance customizable product lines through robust system integrations and process automation.Ensure that integrations are ... RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San… 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
