- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, ... New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with...Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline or relevant experience is… more
- Merck & Co. (Durham, NC)
- …the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures to resolve process/equipment issues, minimize ... effectively with alternate shifts, site Maintenance & Utilities, and Reliability Engineering teams to share best practices, deliver training, and ensure consistency… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... to be incorporated with an automation platform that integrates with MES systems in cGMP manufacturing operations. This effort will extend organizationally to… more
- Eisai, Inc (Exton, PA)
- …External suppliers as needed. 10% Requirements A bachelor's degree in Life Sciences/ Engineering discipline is required. Minimum 5 years' experience in FDA or ... devices. Strong verbal and written communication skills a must Prior electronic systems knowledge required (ie, LIMS, TrackWise, SAP, MS Office, etc.) Domestic and… more
- Catalent (St. Petersburg, FL)
- …legal, and fiduciary policies, practices, and requirements.Collaborate with manufacturing, engineering , validation, information systems , QA, QC, and training ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.The QA Product Manager… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …various projects. The Project Engineer will work directly with the Engineering team, Operations, Maintenance, and Manger of Project Management. Job Responsibilities: ... manufacturing processes and packaging equipment, unit operations, process control systems , computer systems , equipment cleaning, sterility assurance, process,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to develop, document, and implement new measurement methods and test systems .Demonstrated knowledge of programming languages in support of instrument automationGreat ... 50 lbs without assistanceEducation RequirementsBachelor's degree with a technical or engineering focus and/or equivalent military PMEL / TMDE or related calibration… more
- Aequor (Libertyville, IL)
- …incident, problem and change IT operational events (ie ServiceNow). Knowledge of IT systems such as ERP, OSI PI, Client, LIMS, ServiceNow, Celdox and Veeva. ... Knowledge of various IT Systems integration and Agile Methodologies. Knowledge of cGMP, GXP,...a plus. Education and Experience: Bachelor's degree in an engineering or computer management discipline. Must have experience with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the validation team in the establishment and maintenance of validated systems . Coordinate technology transfer activities in support of commercialization. Serve as ... for the validation program, Policies and SOPs and other master documentsSupport Engineering and Manufacturing in the development of critical process parameters and… more
- Merck & Co. (Durham, NC)
- …for assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes.Adapts and ... Job Description GENERAL SUMMARY :The Sr. Tech, Engineering is a member of the Engineering...as boilers, chillers, Cooling towers, air compressors, waste deactivation systems , HVAC, clean steam, WFI. Develops Standard Operating Procedures… more
- Novo Nordisk Inc. (Durham, NC)
- …of engineering experience in process-based manufacturing, utility and/or packaging systems preferred Knowledgeable in the following systems : PLC, SCADA, MES, ... make what matters. The Position Improve reliability of the process control systems to meet current & projected customer, business & regulatory requirements through… more
- Merck & Co. (Durham, NC)
- …units Assist in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes. Quality ... to perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to : Utility Equipment (eg boilers, chillers,… more
- Novo Nordisk Inc. (Durham, NC)
- …establishing & maintaining positive working relationship with internal & external engineering teams & stakeholders, management of vendor & service contracts. ... Relationships Manager or Senior Manager . Essential Functions Lead...plant operation Lead Failure Analysis & Reporting & develop engineering solutions for repetitive failures Lead site shutdown planning… more
- Novo Nordisk Inc. (Boulder, CO)
- …operation. Relationships Specialist, API Manufacturing reports to the Senior Manager , API Manufacturing. The Specialist, API Manufacturing works with Chemical ... Development, Analytical Services, Engineering , Facilities, EH&S, Program Management and Quality Assurance. Essential Functions Responsible for the manufacture of… more
- Catalent (St. Petersburg, FL)
- …The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.II. Basic Function: This ... schedule for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …travel required. Qualifications Education Level: Minimum bachelor's degree in business, engineering , Information systems or other relevant subjects Experience ... with stakeholders across the Finance organization with frequent interaction at the manager , senior manager and director level. Moreover, the job regularly… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …This role will support our QC teams under the direction of the QC Manager . Relationships Reports to: Quality Control Manager Number of subordinates with ... multi-disciplined projects, with minimal supervision Functional understanding/application of quality systems with the ability to manage Change Controls Support… more
- Merck & Co. (Durham, NC)
- …organization is seeking to hire an experienced and technically proficient people manager to lead a team of coaches, production specialists, and operators through ... Purification Suite leadership team, including cross-functional colleagues representing Quality, Engineering /Maintenance, Technical Operations, Validation, and Automation groups Direct interaction… more
