- Repligen (Clifton Park, NY)
- …and incorporate it into the culture. Lead the implementation of the Repligen Performance System (RPS) throughout Engineering . Lead the planning of ... single-use state-of-the-art single use components and innovative storage and transfer systems that optimize fluid transfer and reduces the number of connections… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of 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...established processes.RequirementsA minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline or relevant experience is… more
- Merck & Co. (Durham, NC)
- …calibration teams across the site with limited oversight to focus instrument performance and minimize downtime.Initiate and complete SOP revisions. Lead 8-step ... Job DescriptionJoin our dynamic Engineering , Maintenance, & Utility Department as a Senior...sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and approve out of tolerance… more
- Merck & Co. (Rahway, NJ)
- …meet requirements regarding technical quality, reliability, schedule, and cost.Monitors performance and recommends schedule changes, cost adjustments or resource ... Minimum Education Requirement and Experience: - Bachelor's degree in Chemical Engineering , Bioengineering, Biological Engineering , or a related field with… more
- Merck & Co. (Rahway, NJ)
- …role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... and organization. As the facility is nearing the completion of its' Performance Qualification and Process Simulation execution, the selected candidate will lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …GenAI model interacts correctly within the application Proficiency in improving the performance and efficiency of AI/GenAI models and systems Proficiency in ... AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI...and cultivates essential skills needed for data & AI Engineering , GenAI development, and analytics automation and dashboarding, ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or related field - Required Master's Degree in Computer Science, Life Science, Engineering , or Information Systems - Preferred Experience10+ years of experience ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Novo Nordisk Inc. (Durham, NC)
- …IT or Engineering experience in process-based manufacturing, utility, &/or packaging systems required May consider a High School Diploma or equivalent with a ... years of Engineering experience in process-based manufacturing, utility, &/or packaging systems required Minimum of eight (8) years of Engineering experience… more
- Twist BioScience (South San Francisco, CA)
- …electronic batch record optimization, and advanced data utilization. Ensure robust system performance , availability, and audit readiness through proactive ... DescriptionWe are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation,… more
- Merck & Co. (Durham, NC)
- …opportunity for you!The Associate Specialist, Calibration is a member of the Engineering , Maintenance and Site Services (EMSS) team providing support to the Durham ... events and continuous improvement by thorough analysis of instrument performance .Responsibilities: Individual contributor role working with calibration teams across… more
- Repligen (Rancho Dominguez, CA)
- …device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering , and equipment qualification, preferably within GMP ... Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …passion for creating new medicines.Leadership & People Management: Proven ability to lead cross-functional teams, manage performance , and develop talent. Ability ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... and site-specific projects related to combination products and drug delivery systems .Facilitate the professional development and performance of team members,… 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 ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering , Validation, Technical Support, Supply Chain) that supports daily… more
- Merck & Co. (San Francisco, CA)
- …Awareness, Decision Making, Feasibility Studies, Management Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project ... seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build… more
- Repligen (Rancho Dominguez, CA)
- …contractors and service providers for specialized tasksMonitor and evaluate building systems for performance and efficiencyPrepare reports on facility operations ... Management (eg, IFMA, BOMA)Minimum of 3-5 years of experience in facilities engineering or facilities managementExperience with Building Management Systems (BMS)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …guidelines and operating proceduresSupports the planning, coordination, and performance of timely calibration during shutdownsResponsible for performance ... to identify root cause and appropriate corrective actions for equipment system problemsHelps support the optimization of calibration frequencies through a… more
- Novo Nordisk Inc. (Durham, NC)
- …change management. Lead cross-functional process improvements. Develop plans to improve the performance of a process or set of systems , using green belt ... technologies. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous...the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet… more
- Eisai, Inc (Exton, PA)
- …project priorities, providing scientific leadership and oversight and managing individual performance and cost center budgets. The individual recruits staff as ... that is recognized for successfully bringing operations, science, and engineering principles to bear on advancing Eisai's biopharmaceutical programs. Essential… more
