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Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures. Develop and review comprehensive validation procedures in compliance with FDA.
ExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Good understanding of Pharma CSV (Computer Systems Validation). + yrs testing/validation experience with LS background. Responsibilities: Strong knowledge/experience with LIMS (Laboratory Information Management System), Softmax , ELN (Electronic Lab Notebook) products.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness. Review and approve validation documents (, Project Plans, User Requirements, Protocols, Validation Deviations, Summary Reports, etc) for CGMP and technical content.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Background from Quality Mazaak i200 and EMC Oven Machine Validation. Background from Quality Mazaak i200 and EMC Oven Machine Validation. Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and validation related activities.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Plans, implements a robust cleaning and sanitization program by authoring and leading the sanitization Validation Program for all products and product contact equipment. Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies; and relevant Fareva SOPs.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Be the site SME on validation of laboratories, facilities, utilities, quality systems and databases and production operations. 5+ years of experience in validation in biologics environment.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Verifying system drawings including ability to review and as built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Develop validation plans, protocols and reports for assembly and packaging processes. Perform statistical analysis of validation and production data. Develop test method validation (TMV) protocols and reports for automated and manual inspection methods.
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Ensure protocols adhere to in CFR Part and EU Annex and are aligned with quality policies, procedures, and the Validation Master Plan (VMP) of the Gaithersburg site. Ensure protocols adhere to in CFR Part and EU Annex and are aligned with quality policies, procedures, and the Validation Master Plan (VMP) of the Gaithersburg site.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and other departments to support process validation activities. Minimum of 3 years of experience in process validation within the pharmaceutical or biotechnology industry.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.) Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies. Responsibilities: Designs and drafts validation sampling and testing plan/protocols.
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The client needs an Equipment Validation Engineer to come onboard 6 months. Most Important Skills: Equipment Validation, Validation, Installation, IQ, OQ, PQ , Prefilled Syringes.
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Responsibilities: Demonstrated delivery of Associate Validation Engineer level requirements. Demonstrated capability to deliver on the Validation Engineer 1 Responsibilities.
ExpandApply NowActive JobUpdated 6 days ago
Title: validation engineer Company: Katalyst Healthcares Life Sciences
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