- Merck & Co. (Rahway, NJ)
- …Engineering ). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical ... Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring… more
- Merck & Co. (Rahway, NJ)
- …systems and other strategies that-optimize-statistical efficiency and quality .Develop and-maintain-Site Facility Energy Regression models.Work with Operations ... vs. replacement.Qualifications, Skills & Experience Required Bachelor's degree in engineering , science technology, automation, mathematics, or statistical analysis with… more
- Merck & Co. (Durham, NC)
- Job DescriptionJoin our dynamic Engineering , Maintenance, & Utility Department as a Senior Specialist, where you will play a crucial role in enhancing asset ... and driving manufacturing excellence in a fast-paced environment. Utilize your engineering expertise and leadership skills to empower teams, solve complex technical… more
- Merck & Co. (Rahway, NJ)
- …activities with the clinical, regulatory, formulation, commercial and other key company functions. Lead the Device Engineering Sub-Teams focused on development of ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise 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 position with responsibilities for supporting the quality systems processes within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is tasked ... that: Attracts and cultivates essential skills needed for data & AI Engineering , GenAI development, and analytics automation and dashboarding, ensuring the team… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12… more
- Repligen (Hopkinton, IA)
- …inconsistencies.Communicate effectively with supervisors and other departments (maintenance, quality , engineering ).Assist with scheduling, timekeeping, and ... OverviewThe Manufacturing Line Lead 2nd Shift reports to the Production Manager...a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the… more
- Merck & Co. (Rahway, NJ)
- …compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or ... Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- BioAgilytix (Durham, NC)
- …for building a high-performing data management team, identifying roles in data engineering , quality , and automation as the function matures.Sponsor Data Delivery ... That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... Team Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and… more
- Merck & Co. (Rahway, NJ)
- …standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will have strong ... strategies that ensure compliance with GxP (as applicable) and other regulatory requirements. Lead the operation of the site BAS and HVAC control systems. Manage… more
- Merck & Co. (Rahway, NJ)
- …ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation and/or ensure effective execution of the ... / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for program presentations for management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of commercial and clinical capacity.Build strong partnerships with Manufacturing, Supply Chain, Engineering , MS&T, and Quality to ensure seamless execution of ... 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. (Durham, NC)
- …the Master Data team with general Material Handling Steward tasksDrive safety, quality and process enhancements throughout the supply chain - Project Management ... Lead and sponsor all Supply Chain Logistics initiatives surrounding...project implementations. Educational requirements: Required:B.S./BA Degree in Science / Engineering / Business or Supply Chain Management- Required experience… more
- Merck & Co. (Rahway, NJ)
- …functional representatives, is responsible for ensuring the reliable supply of quality products at competitive costs from external manufacturing partners (EPs) and ... boundaries and ground rules for engagement with the EPs, while ensuring compliance/ quality readiness of these suppliers at all times through the implementation of… more
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated environment. The… more