- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment , systems, computer systems, ... studies, and any associated documentation in support of computer systems validation , equipment , utilities, and facility qualification, process validation… more
- Eisai, Inc (Exton, PA)
- …operation, and CIP/SIP operations. Knowledgeable in process development, technology transfer, equipment scale-up, equipment validation , and facility startup. ... Supervise change-over activities. Be responsible for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for ... Cell/Gene Therapy experienceMinimum of 5 years of experience of progressive leadership roles in a cGMP operation, with prior Biologics and/or cell therapy operations experience preferred.Prior experience leading large multilevel teams.A history of developing… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... with company policies, SOPs, and state, federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP… more
- Repligen (Rancho Dominguez, CA)
- …Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. ... is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer between sites Data… more
- Merck & Co. (Rahway, NJ)
- …INDs and NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive ... scientific staff from a budgetary and personnel decisions standpoint.Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is… more
- Merck & Co. (Rahway, NJ)
- …approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment , critical utilities, and computer systems.- ... Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation plans and annual reports around critical equipment and… more
- Merck & Co. (Rahway, NJ)
- …and understanding of project / engineering work process and deliverables (eg, equipment fabrication, FAT, SAT, qualification / validation )Current Employees apply ... HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems. ... and weekend on call support as needed Technical requirements for Validation and of biopharmaceutical equipment , facilities and/or instrumentation preferred… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and related issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including ... for the design and implementation of manufacturing processes, instrumentation, and equipment start-ups from the laboratory through manufacturing scale. This role… more
- Merck & Co. (Rahway, NJ)
- …AR&D network. The role oversees and supports the onboarding, qualification, validation , and routine maintenance of analytical equipment and instrumentation ... Validation (CSV), Data Analysis, Diversity and Inclusion (D&I), Equipment Maintenance, Experimentation, GMP Compliance, GMP Environments, Inventory Management,… more
- BioAgilytix (Durham, NC)
- …for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass ... project deliverables with client timelines and expectations.Lead assay development, validation , and sample analysis of biologics, proteins, peptides, ADCs, and/or… more
- BioAgilytix (San Diego, CA)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... with clients to assure successful on time execution of assays, validation , and sample analysis under GxPs.Prioritizing tasks and managing schedules efficiently.Meet… more
- Insmed Incorporated (San Diego, CA)
- …and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage ... techniques like HPLC, Capillary Electrophoresis, ELISA, ddPCR, and various spectroscopic equipment . This involves assessing properties of AAV drug candidates and… more
- Lundbeck (Bothell, WA)
- …a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to… more
- Aequor (Tampa, FL)
- …participates in customer and regulatory audits as area SME. Develops and executes validation protocols for test methods and equipment qualification. Author and ... Carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of… more
- Merck & Co. (Durham, NC)
- …(CIP) Systems-Maintenance Equipment (eg tools and calibration equipment )-Assist with execution of calibration, automation, validation and ... and troubleshoot complex process systems, including but not limited to:Utility Equipment (eg boilers, chillers, Cooling towers air compressors, waste deactivation… more
- Merck & Co. (Durham, NC)
- …for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, ... activities.- Completes complex maintenance tasks, resolves deviations and evaluates equipment performance.- Follows proper procedures for maintaining production … more
- Merck & Co. (Durham, NC)
- …the globe. The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, ... activities.- Completes complex maintenance tasks, resolves deviations and evaluates equipment performance.- Follows proper procedures for maintaining production … more
- Aequor (East Syracuse, NY)
- …work. The laboratory work requires appropriate levels of personal protective equipment (PPE). The role may require contact with biohazardous materials such ... for supporting analytical method lifecycle activities including method development, qualification, validation , and technical transfer of methods for the testing of… more
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