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Reporting to the Senior Manager process Validation, the Process Validation Engineer III/IV is accountable for guiding teams and performing validation activities such as Performance Qualification (PQ), Process Validation (PV) and Revalidation (RV) in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products. Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Ensure all development work is fully captured intechnical reports, tech transfer and cGMP production records with process development andcharacterization conducted consistent with QbD principles, risk assessments as needed, andprocess validation as appropriate and in compliance with regulatory expectations.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The role will contribute to refining QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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3-5 years’ in pharmaceutical manufacturing involving change control, quality assurance. Support Document Control, Training Program, stay informed on regulations, cGMP trends, FDA/ICH Guidelines.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Document Control Specialist is responsible for managing and maintaining all pharmaceutical CGMP related documents within the organization. Denison Pharmaceuticals is a leading provider of turnkey formulation, manufacturing and packaging solutions for the OTC, Cosmetic, Homeopathic and Pharmaceutical markets.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Instrument Engineer associate for our USA office (Indianapolis) to be assigned to our Instrument Services (ISP) team.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP). Demonstratable working knowledge of corporate Quality Management Systems, current Good Manufacturing Practices (cGMP), and Good Clinical Practice (GCP.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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This position will provide corrective action, basic troubleshooting, and intermediate repairs of equipment such as mechanical (HVAC & plumbing), general facilities infrastructure, life safety, utilities and more within a cGMP manufacturing facility.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP). Knowledge of IRT system setup and functionality and proficiency with Excel modeling. Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.
Full-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Minimum of 2 years of experience working in industrial environments such as pharmaceutical manufacturing and related settings. Should not have any restriction to work with powder containing active pharmaceutical ingredients.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Must have knowledge and experience with cGMP manufacturing, Quality, and compliance. B.S degree with 1-3 years GMP experience in the Pharmaceutical or related industry. Knowledge and experience with cGMP activities.
ExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Mechanics are responsible for the setup, operation, adjustment and repair of pharmaceutical packaging equipment. Understand and adhere to all cGMP and FDA regulations. Mechanics are responsible for the setup, operation, adjustment and repair of pharmaceutical packaging equipment.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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5+ years of MES experience in Pharmaceutical, Biotech, or Life Sciences industries with 5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations. Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Minimum of 0-3+ years post-Bachelor degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in the pharmaceutical/ biotech industry.
$35 - $40 an hourExpandApply NowActive JobUpdated 12 days ago
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