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Perform testing for Artiva's cGMP EM program, including non-viable particulate monitoring, viable air, and surface monitoring using aseptic technique. At least 3-5 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
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Job activities include the preparation of equipment and components for aseptic filling operations, performing visual inspection of filled vials, vial labeling, vial packaging and distribution of filled vials as per GMP regulations.
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Previous experience with combination products, device assembly, pharmaceutical packaging, and filling in aseptic environment. 7+ years demonstrated ability in a GMP FDA, cGMP, ISO, or other regulated production environments.
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Preferred Attributes: Experience with, completion of, or understanding of: 4 years in manufacturing/operations with 2 years in supervisory role cGMP standards and FDA (or other industry) guidelines for production STEM degree or certification Aseptic filling, single use assemblies, isolator technology.
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Knowledge of cGMP for aseptic/ clean room manufacturing. Preferred Qualifications: Lean Six Sigma Black Belt (or Green Belt with solid track of lean improvements). Required Qualifications: Education: Bachelor's in Engineering or Sciences Must have 2-3 years of experience in Biotechnology/Pharmaceutical manufacturing.
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Candidate must have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
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Serve as a technical expert to receive the technology transfer from Development to cGMP manufacturing. This position will be involved with both upstream and downstream processes using aseptic processing techniques in a cleanroom environment.
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Biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream. Experience in aseptic processing techniques and some understanding of regulatory requirements for a cGMP manufacturing facility.
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Demonstrated knowledge in Microbiology and aseptic techniques. Minimum 0-2 years relevant laboratory experience or experience in a cGMP and/or FDA regulated industry or a combination of education and related work experience required.
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Perform facility cleaning of critical aseptic environment as required to maintain a cGMP environment and in accordance with Standard Operating Procedures. Assist in the bulking/filtration process prior to aseptic filling.
$19.36 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Must have a thorough knowledge of cGMP and regulatory requirements for validation of equipment and computerized systems in the biopharmaceutical or pharmaceutical industry. Utilize isolator and VHP decontamination to enable Aseptic processing of Pharmaceutical products.
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The Manufacturing Technician is responsible for the aseptic manufacturing of tissue-based (human and porcine) products for the regenerative market. To ensure product quality, this role much adhere to standard procedures and cGMP.
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Develop and approve cGMP documents including, but not limited to: Validation Protocols and Reports, Commissioning Reports, Master Validation Plans, SOP’s, Comparability Reports, Aseptic Process Simulation Protocols and Reports, Cleaning Validation, Process Validation (PPQ.
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This position is responsible for managing the Bedford Site’s Validation program that includes start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines.
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Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable. Ensures compliance with current Good Manufacturing Practice (cGMP) and maintain constant inspection-readiness.
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