- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... as an engineering resource for biologics operations, build strong equipment knowledge, lead projects, and provide guidance and training to operationalize the GMP… more
- Merck & Co. (Millsboro, DE)
- …Belt or higher (LL2/LL3), or equivalent experience.Experience with SAP and inventory control systems .Familiarity with kata and other lean coaching tools.Current ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality… more
- Merck & Co. (Durham, NC)
- …6:30 PM; 6:00PM-6:30AM) rotation ( 2-2-3).- - The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with ... expertise working in aseptic production and manufacturing operations. The Lead Technician is a manager developmental role and will serve on the Operations leadership… more
- Eisai, Inc (Exton, PA)
- …we want to hear from you. Primary responsibility will be to maintain the various control systems throughout the pilot plant facility as well as the laboratory ... building. The control systems include process skids, clean utilities,...systems in direct support of Pilot Plant operations. Lead , coordinate and oversee development of projects design documents.… more
- Merck & Co. (Durham, NC)
- …activities are tracked and completedDevelops detailed understanding of design, construction, control and maintenance of building systems and process equipment. ... with safety, production, and quality groups to ensure facility operations and systems comply with required standards. Lead / participate in discussions with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control ... System - Device Design Control will be responsible for device design control activities in the following aspects: Lead and contribute device development… more
- Merck & Co. (North Wales, PA)
- …processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical ... strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.Essential Duties and Responsibilities:The engineer will… 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 ... specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems .Proven expertise in design controls, risk analysis, control … more
- Repligen (Clifton Park, NY)
- …technicians or project teams.Strong problem-solving skills with mechanical, electrical, and control systems (motors, drives, sensors, packaging lines).Skilled in ... as a technical subject matter expert (SME) and team lead . The position also plays a key role in...emergency repairs across mechanical, electrical, pneumatic, hydraulic, and utility systems .Serve as SME for critical systems ; guide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process ... collaboration with business functions. Provide expert guidance to enable successful inspections. Lead /Support local inspections by providing adequate systems and… more
- Merck & Co. (Rahway, NJ)
- …and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control , Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance, ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The associate director will be a technical subject matter expert on the ... device components and combination products and lead a cross functional team members to support global commercialization and technology transfer activities and drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal ... contact and support all signal management activities. They will lead the safety signal governance and develop, or update...maintenance of signal tool and support tasks of change control , training material update, and end user support or… more
- Merck & Co. (Rahway, NJ)
- …a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation .-- - Under the guidance of dCMC Regulatory A ... - Stakeholder Management & Communication : The analyst will organize and lead information gathering sessions with the internal CMC community, collaborate with… more
- Merck & Co. (Rahway, NJ)
- …clinical development programs, clinical trial processes as well as quality management systems and quality control tools.Expert knowledge of GCP/ICH and worldwide ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality… more
- Merck & Co. (Rahway, NJ)
- …of automation to DD&T process workflows to enhance accuracy and reduce lead times.In collaboration with DD&T staff and our Company's Research & Development ... ImplementationOversee the selection, implementation, and optimization of inventory management systems (IMS) and automated solutions specific to DD&T assets.Integrate… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... testing and qualification and leading execution of qualification of complex systems .-The candidate is expected to build inclusive, collaborative partnerships with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThe Facility Engineer will be responsible for ensuring equipment/ systems required to support an expanding Cell Therapy facility is appropriately ... deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems… more
- Merck & Co. (Rahway, NJ)
- …of scientists and engineers who are responsible for delivering robust packaging systems for cell banks, drug substance, drug product, and finished goods.- ... the design, characterization, qualification, and tech transfer of robust packaging systems to commercial sites, as well as packaging process co-development with… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and ... characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA… more
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