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The Facility & Reliability Engineer will also support the successful operation of facility, laboratory, and business functions at multi-use GMP sites within client, Summit West Cell Therapy Operations, through interaction with internal customers and external service providers.
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Generates SOPs and Work Practices within Celgene’s Document Management System and electronic work plan template and measurement data templates to establish the Use, Maintenance and Calibration plans for GMP equipment.
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Responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and assist in method qualification/validations. They may also support other microbiological testing methods, laboratory support/maintenance, assist in drafting SOPs/protocols, and support cell therapy manufacturing operations.
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Years of experience in Pharmaceutical Manufacturing preferred, at least years combined of relevant experience in quality-based roles including experience in GMP and/or laboratory operations required.
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Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements. This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facility operations to ensure the efficient completion of these laboratory-based projects.
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Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes. The Equipment Technician, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory, clinical and commercial manufacturing operations at their home site through interaction with internal team members and internal customers as well as external service providers.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The lab technician will provide support for scientists in fast-paced and dynamic R&D and GMP laboratory areas. No experience required; laboratory experience preferred. Clean laboratory glassware, dispose waste, and maintain an orderly laboratory.
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Escorts Field Service Engineers performing calibration, preventative maintenance, performance verification, and repair activities in both laboratory and manufacturing areas. Work with Equipment Commissioning and Qualification Engineers to maintain organization of storage and laboratory areas utilized by Equipment Commissioning and Qualification.
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The QA Validation Specialist will be responsible for management of the GMP quality assurance oversight of Qualification, Validation, in relation to Facility Equipment, Computerized Systems, Laboratory systems in order to meet our regulatory requirements in Millburn, NJ.
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Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Serve as SME for the GMP regulatory inspections, specifically for qualification and validation matters. Represents site QA Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site.
$88,000 - $132,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Review/approve investigation of operations in manufacturing/laboratory or other related operations. Review and approve changes related to facility, computerized systems, laboratory or products.
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Experience in at least one of the following: HPLC, ELISA or Capillary Electrophoresis techniquesDay to Day Responsibilities: Using analytical equipment in the laboratory with minimal supervision.
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Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes." " Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
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Primarily an office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes. 5 years’ experience performing/supporting activities in a GMP environment.
$70 - $73 an hourExpandApply NowActive JobUpdated 2 days ago
gmp laboratory jobs in Newark, NJ
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