- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Change Control Specialist as part of the Technical Operations team based in Raritan. ... Role OverviewThe Change Control Specialist will be part of the Technical Operations...the safety policies, quality systems and cGMP requirements.Drive change controls to ensure on time completion and ensure change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control , Operations Technical Support, ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Document Control Specialist as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …of engagement in all device development activities (eg engineering design, engineering analysis and testing, medical device design controls , risk management, ... and development, manufacturing process development, qualification and validation, design controls and device risk management techniques to positively support and… more
- Merck & Co. (Rahway, NJ)
- …for commercializing new products.Technical Expertise:Utilize extensive experience in design controls , device transfer, control strategies device risk management, ... prefilled syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies, design verification testing, and… more
- Merck & Co. (North Wales, PA)
- …as certain defined analytical materials or samples that require formal control or execution coordination through Large Molecule Analytical Sciences (LMAS).- This ... work plans (issued/approved by the LM Critical Reagent Planning and Controls ) Participate and execute internal and cross functional strategic planning activities,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking Sr. Asset Reliability Engineer as part of the Facilities & Engineering team based in Raritan, NJ. Role OverviewThe Asset / Reliability Engineer will ... for equipment optimizations as well as system upgrades with the systems engineering team. This role will require technical expertise and troubleshooting ability and… more
- Merck & Co. (Rahway, NJ)
- …candidate, you should have advanced graduate degree(s) in an engineering or closely-related scientific discipline, and industrially-relevant experience in process ... chromatography modeling, end-to-end flowsheets and digital twins, model-based process controls , plant and process-economics (including facility fit, cadence, scheduling,… more
- Merck & Co. (South San Francisco, CA)
- …with academic and industry partners to accelerate the pace of biologics discovery and engineering .-We recognize that the diversity in our team is our strength and we ... and application of computational tools that enable the discovery and engineering of biologics.- They will partner broadly across Discovery Biologics, Data… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with cross functional groups like manufacturing, QC, Facilities, MSAT, process engineering and other departments liable for GMP activities, to support investigation ... understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical … more
- Insmed Incorporated (San Diego, CA)
- …GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego, ... CaliforniaResponsibilitiesQA support of Quality Control :Approve or reject starting materials, packaging materials, labelling and intermediate, bulk and finished… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support, Supply Chain and ... according to cGMP requirements. This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and… more
- Merck & Co. (Durham, NC)
- …biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. This position requires the ability to work independently ... to advance project goals. Manage area metrics/KPIs/schedule Assist in developing operations controls and metrics to display the overall health of the project.… more
- Merck & Co. (Rahway, NJ)
- …Minimum Education Requirement and Experience: Bachelor of Science (BS) degree in Science, Engineering , or related area of study with five (5) years prior experience ... thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and...requirements; OR Master of Science (MS) degree in Science, Engineering , or related area of study with three (3)… more
- Merck & Co. (Rahway, NJ)
- …areas: Process Cell Sciences (PCS), Upstream and Downstream Process Development & Engineering . The latter two together form our Biologics' Process Development (BPD) ... graduation within 6 months from date of application) in Chemical Engineering , Biochemical Engineering , Biomedical Engineering , Biotechnology, Biochemistry,… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)-Clean-In-Place (CIP)… more
- Merck & Co. (North Wales, PA)
- …is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises ... and health authorities.Education Minimum Requirement: -B.S. in a biological science, engineering , or a related field (advanced degree preferred).- -Fields of study… more
- Merck & Co. (Rahway, NJ)
- …to collaborators. Education Requirements A Ph.D. in Chemistry, Biochemistry, Engineering , Data Science, Mathematics, Physics, Biology, Pharmaceutical Sciences, or a ... closely-related field A MS in Chemistry, Biochemistry, Engineering , Data Science, Mathematics, Physics, Biology, Pharmaceutical Sciences, or a closely-related field… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in global forums/ team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.Provide support to quality ... the creation, assessment and closure as needed of corrective actions, change controls , or audit actions related to the siteEnsures and maintains a state… more
- Aequor (Framingham, MA)
- …Cell Culture Development, Process Analytical Technology, Data Sciences, Automation Engineering and Bioanalytics teams at the client.Key responsibilities Develop, ... (2-4 years) or PhD degree (0-2 years) in Biotechnology, (Bio)Chemical engineering , Biology, Biochemistry, or a related field. Relevant knowledge, coursework and/or… more
- Merck & Co. (Durham, NC)
- …site's contractor safety culture as well as site safety culture in the Engineering , Maintenance and Site Services (EMSS ) team. Additionally, work with other ... audits of HRW activities for contactorsReview and walkdown Hazardous energy control procedures (HECP) revisionsWalkdown jobs with engineers and technicians to… more
