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Knowledge of validation lifecycles for computerized systems (CSV), aseptic processing, sterilization validation, and equipment/facility/utility validation. Support the Validation Manager by ensuring effective implementation and maintenance of the Validation program.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure that system are qualified in accordance with applicable regulatory agencies, clients and Lonza specifications/requirements.
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This Packaging Engineer (Consultant) will provide guidance, ownership, and execution of all packaging design, sterilization validation, and sustainability efforts for multiple Class III medical devices.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Min 3-5 yrs of exp writing, approving, and executing validation protocols and reports, specifically in the following areas: Process Validation, Sterilization, Equipment/Utility Qualification and Computer System Validation.
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Entry level knowledge of validation lifecycles for computerized systems (CSV), aseptic processing,sterilization validation, and equipment/facility/utility validation. ∙Previous experience with mechanical validation, computer system validation (CSV), change control,CAPAs/deviations, data integrity, and project management required.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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LI-CM1 Education Degree Bachelor's Degree Required Experience Must have 8 years of demonstrated experience in Qualification/Validation/Servicing of process equipment used in sterilization, critical utilities, and instrument cleaning, such as Steam Sterilizers, Pure Steam Generators, and cGMP Washing equipment using cGMP, ISPE, GAMP, ASTM, or ICH guidelines.
$77,800 - $104,727 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required. Provide guidance and leadership on development /review of validation policies, master plans and schedules, and protocols and quality engineering issues.
$105,000 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Develop laboratory services team into an industry leading organization delivering custom products and testing/consulting services to meet customer's unique and challenging requirements with sterilization, cycle development and validation.
$150,000 - $180,000 a yearExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Dispensing, labeling, transfer/staging of raw materials and parts Assembly/disassembly, cleaning and sterilization of components, parts, and equipment Maintaining equipment, area, and cleaning logbooks Cleaning sanitizing production rooms and equipment Stocking production and cleaning supplies May author/ review/improve SOP’s, batch records, protocols, and technical reports Actively participates in training activities, managing their individual training plan.
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Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment. ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
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Assist in testing validation/revalidation activities for critical systems and sterilization equipment with minimal supervision. You will perform routine and non-routine testing to support validation/revalidations of critical systems and sterilization equipment, identification of bacterial/fungal isolates, evaluation of inactivation rates of organisms, product resistance studies, prepares general test data summaries, trend charts, protocols and reports.
$51,000 - $72,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Principal Scientist/Engineer – Cleaning Validation/Sterilization Validation – Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies.
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Leading start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes.
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Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods. You may support CQV (Commissioning, qualification and validation), shut-down, and project hand-over activities.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ). Must understand the fundamentals of one of the following sterilization techniques: gamma irradiation, ethylene oxide.
$80,000 - $85,000 a yearExpandApply NowActive JobUpdated Yesterday
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