- Merck & Co. (Rahway, NJ)
- …molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice ( GMP ) clinical manufacturing plant in Rahway, New Jersey. The Sterile ... aseptic formulation, aseptic filling, and visual inspection.This role require adherence to GMP procedures, strong attention to detail in completing GMP … more
- Merck & Co. (Rahway, NJ)
- …Operations, is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in ... inspections of facilities or operations in supported areas, including GMP Certification inspection.Education Minimum Requirement:-B.S. in appropriate Science or… more
- Merck & Co. (Durham, NC)
- …calibration, assigned capital project work, and support Good Manufacturing Practice ( GMP ) operations for all facility shutdownsCoordinates with Site Engineering and ... VFD's, and automation (BAS) systems in a Good Manufacturing Practices ( GMP )environment.Must be fully aware of requirement specifications from a qualification… more
- Merck & Co. (Durham, NC)
- …Required Experience and Skills: Minimum 1-year relevant work experience in GMP environment Demonstrated written and verbal communications skills Must be willing ... Cleanroom Gowning, Communication, Computer Literacy, Equipment Set Up, Fabrication Processes, GMP Compliance, GMP Environments, GMP Operations, Good… more
- Merck & Co. (Rahway, NJ)
- …related to pharmaceutical drug substance and drug product development, GMP compliance in commercial manufacturing and data integrity.Responsibilities Include:Lead ... guidances (eg, ICH) for drug substance and/or drug productWorking knowledge of GMP and data integrity and recent industry trends in commercial production… more
- Merck & Co. (Durham, NC)
- …and coordinates work with other team members.Competent execution of GMP documentation related to Production operations.Perform liquid media formulation ... and a general knowledge of company policies/guidelines, safety/environmental regulations, and GMP 's.Gain a working knowledge of the production process by becoming… more
- Merck & Co. (Rahway, NJ)
- …drug product design from the bench top to the Good Manufacturing Practice ( GMP ) manufacturing facilities, our Scientists use cutting edge science to transform drug ... new solid oral drug products. - Capability to support manufacturing operations in non- GMP and GMP environments. - Executes routine experiments and data… more
- Merck & Co. (Durham, NC)
- …Electrical, or Instrumentation.Experience working in a clean room or GMP -regulated manufacturing environment.Familiarity with automated process equipment in the ... biopharmaceutical field.Knowledge of GMP -compliant calibration and/or maintenance database systems.Experience with SAP, DeltaV, and ProCal systems.Physical… more
- Merck & Co. (North Wales, PA)
- …competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP , Safety Standards, Project mgmt., Preventive & Predictive maintenance, ... and initiation, through project close-out.Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment… more
- Merck & Co. (Durham, NC)
- …manufacturing operationsGood oral and written communication skillsExperience with GMP compliant calibration and maintenance databasesProject management experience ... the pharmaceutical industryExperience working in a clean room or GMP /regulated manufacturing environmentFluent with SAP, Maximo or another computerized maintenance… more
- Merck & Co. (Durham, NC)
- …process systems including PAS-X, DeltaV, SAP, RtReports, GLIMSAt least four (4) years GMP manufacturing/processing experience or at least two (2) years GMP ... Literacy, Data Analysis, Environmental Monitoring, Environmental Sampling, Equipment Maintenance, GMP Compliance, Good Manufacturing Practices ( GMP ), Inventory… more
- Merck & Co. (Lower Gwynedd, PA)
- …compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice ( GMP ). The Associate Principal Scientist will lead cross-functional teams, providing ... Cell-Based Assays, Communication, Computer Science, Data Analysis, Detail-Oriented, DMPK, GMP Compliance, Good Manufacturing Practices ( GMP ), GxPs, Immunoassays,… more
- Merck & Co. (Durham, NC)
- …Required Experience and Skills: Minimum four-year relevant work experience in GMP environment Demonstrated written and verbal communications skills Must be willing ... Manufacturing, Communication, Computer Literacy, Customer Experience Management, Fabrication Processes, GMP Compliance, Good Manufacturing Practices ( GMP ), Inventory… more
- Merck & Co. (Durham, NC)
- …and Skills:Familiarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsPhysical requirements ... of Equipment, Equipment Maintenance, Equipment Troubleshooting, Field Failure Analysis, GMP Compliance, Good Manufacturing Practices ( GMP ), Lockout Tagout,… more
- Merck & Co. (Lower Gwynedd, PA)
- …adhering to Good Laboratory Practice (GLP) and Good Manufacturing Practice ( GMP ).-As an Associate Principal Scientist, you will mentor junior scientists, foster ... Science, Cross-Team Collaboration, Detail-Oriented, GLP Regulations, Good Manufacturing Practices ( GMP ), GxPs, Immunoassays, Immunochemistry, Immunology, Laboratory Informatics, Laboratory Information… more
- Lundbeck (Bothell, WA)
- …Center of Excellence at cutting edge of innovation and technology advancement. Support GMP characterization of MCB, WCB and LIVCA end of production cell banks. ... chemistry, or related discipline. Experience in CHO cell line development for GMP applications within the biotech or pharmaceutical industry. Working knowledge of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspections, and lead investigations to ensure process integrity and GMP compliance. Additionally, the role includes overseeing and enhancing manufacturing ... vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered autologous T cell therapy products.Write and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility is appropriately purchased, qualified, deployed and maintained following necessary GMP requirements. This person will be the lead for equipment ... of experience in Facility, Engineering, and/or Operations in a GMP production environmentExperience in biotechnology or Cell Therapy preferredExperience managing… more
- Repligen (Clifton Park, NY)
- …standards.Support quality systems including CAPAs, deviations, audits, and GMP documentation.Collaborate with cross-functional teams on projects, validations, and ... lines).Skilled in troubleshooting AC/DC systems, PLCs, and automation systems.Familiar with GMP , FDA, NEC, and NFPA70E compliance standards.Proficient with MS Office… more
- Monster (Durham, NC)
- …to join a leading biotech company in the Durham, NC area as a GMP Technician (Quality). This 12-month contract role offers a unique blend of document control ... recent acquisition into company systems, ensuring compliance and accuracy. Support GMP document control processes, maintaining proper organization and adherence to… more
