- Repligen (Hopkinton, IA)
- …detailed visual inspections, operating manual and automated machinery, and completing packaging and labeling activities. The successful candidate will play a key ... according to Good Documentation Practices (GDP)Learn the Repligen Performance System and contribute to a culture of continuous improvementOther Duties:Please… more
- Aequor (Hicksville, OH)
- Packager - Support Specialist 2nd shift Packaging = /hr pay rate rd Shift Packaging = /hr pay rateImportant that they are able to work on the 1st shift (6:45 am ... up and monitoring all batches. Major Accountabilities Provides direction/line assignments to packaging personnel. Starts up production lines at the beginning of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning ... per study and providing the signal for sourcing, manufacturing, packaging , and distribution- for our company development products and...and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Merck & Co. (Rahway, NJ)
- …of clinical trials. -GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites globally. The GCS ... needs per protocol and ensuring a robust signal for packaging and distribution for Clinical Finished Goods (CFGs)-Analyzes and...IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for… more
- Novo Nordisk Inc. (Durham, NC)
- …(10) years of IT or Engineering experience in process-based manufacturing, utility, &/or packaging systems required May consider a High School Diploma or ... of twelve (12) years of Engineering experience in process-based manufacturing, utility, &/or packaging systems required Minimum of eight (8) years of Engineering… more
- Merck & Co. (Rahway, NJ)
- …clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning ... assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for...authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to… more
- AUROBINDO (Durham, NC)
- …the information in the packing slip and issued PO Store API, Excipient, Packaging and Printed components and other inventory controlled items on qualified location ... of material movement within the warehouse.(If required).Perform sampling of printed packaging materials. (If required).To verify printed packaging material as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and replenishment. This individual will also work with inventory management systems and execute cycle count and reconciliation activities to ensure inventory ... perform safety and quality audits, and answer relevant questions about packaging , methods, storage, and inventory for internal and external stakeholders. This… more
- Aequor (Davie, FL)
- …:1. Electrical field degree with a minimum of 2 years working with electrical systems (24v - 480V) and utilities (HVAC, Boilers, water systems , cooling towers, ... is a plus (pharmaceutical, biotechnology, medical devices, vitamins or packaging )3. Spirometry & OSHA Respirator Questionnaire4. Lifting Assessment (35Lbs)… 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 staff to ... site-specific projects related to combination products and drug delivery systems .Facilitate the professional development and performance of team members, fostering… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- BioAgilytix (Durham, NC)
- …sponsors need on tight deadlines. You'll harmonize results from multiple sites, package them in industry-standard formats, and automate the hand-offs so exports ship ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... improve performance.Apply technical skills and ingenuity to correct equipment and system problems that result in downtime or consume excessive maintenance resources… more
- Repligen (San Diego, CA)
- …by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and ... and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system … more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …R related system and technology. Develop and drive R programming, package , and R shiny app development. Lead the R programming implementations. Represent ... as R programming SME and functional representative of R systems and infrastructure to identify system and...and difficulties. Lead the trainings and implementations of R system and programming technology.- Developing R package … more
- Novo Nordisk Inc. (Durham, NC)
- …Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients ... the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet...improve the performance of a process or set of systems , using green belt concepts. Develop & manage project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe...define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data… more
