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Project execution, product and system troubleshooting, workshop instructions and on-site equipment support, technical documentation, technical planning, customer interface, product design review and validation, product maintenance, upgrade/conversion, repair, and refurbishment.
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Write, review, and approve technical CQV documentation including standard operating procedures, validation plans, execution plans, risk assessments, summary reports, URS, FRS, design specifications, testing protocols, and so on.
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The Systems Engineer will be responsible for but not limited to: Performs requirements analysis, technical planning, documentation updates, system integration, verification and validation for space systems.
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Interface with the Packaging Engineer, Packaging Design and external suppliers to develop mockups for evaluation and selection. The GPO Intern will play a support role in facilitating the qualification of various finished goods packaging sites by drafting and coordinating documentation approvals and conducting crucial ERP transactions.
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Ensuring Risk Management is effective utilizing feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HHAs, etc. Supporting the creation and review of all medical device software documentation including Software Development Plans, Software Safety Classification, Software Design Verification test plans, regression plans, and associated test protocols and test reports, software issue tracking and resolution, cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.
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This role includes generation and maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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MannKind Corporation has an opening for a Automation and Controls Engineer-II, in Danbury, CT. DUTIES : Act as a first responder to line related automation, instrumentation, and equipment issues.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Broad-based background in pharmaceutical manufacturing with a combination of experience and skills in one or more of the following areas: product/ process development, production support, engineering, validation or quality assurance.
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You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.
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Reviews, Revises and Writes Standard Operating Procedures, study design plans, qualification and/or validation protocols, investigational test plans, investigation reports, change control requests and other operational documentation.
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Product / Process Validation & Transfer Support additional manufacturing sites Manufacturing Equipment Specification & Design – concept, qualification, FAT Interact with industry OEM equipment, material, and tooling to develop and improve performance/ quality/supply.
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Demonstrated skills in software engineering methodology including documentation, configuration management, verification and validation, and commercialization. The person hired for the 3D Web Software Engineer position will be an active member of a high-performance software development and systems engineering team working in an agile environment.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Knowledge of good documentation practices and cGMP. SALARY RANGE FOR THIS ROLE IS $95,000 - $110,000 ANNUALLY FOR A W2 EMPLOYEE VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.
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Production process development, documentation, optimization and validation. - Act as lead engineer on a variety of projects and participates in the project planning of major sub-projects.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Capability studies, scrap reduction, new model quality, PPAP, APQP, PFMEA, containment, RCA, root cause analysis, capability studies, line validation, quality checks, counter measures, PQCT, control plans, investigations, quality supervisor, quality engineering, quality coordinator, QA engineer, QA supervisor, QA coordinator, quality assurance.
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