• Supervisor, Engineering Operations (2nd Shift…

    GRAIL (Durham, NC)
    …control software). + Coordinate preventive maintenance, calibration, and equipment onboarding validation activities, ensuring alignment with **QMS and FDA ... performance and uptime. + Partner with R&D, Software, and Quality teams on system changes, new equipment validation , and controlled rollouts. + Ensure vendor… more
    GRAIL (08/22/25)
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  • Principal, Quality Assurance, GMP

    West Pharmaceutical Services (Exton, PA)
    …expert guidance on regulatory and industry standards concerning data integrity, including computer system validation , audit trails, electronic signatures, ... and industry expectations in terms of data integrity requirements: computer system validation , audit trail,...SME group. + Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as… more
    West Pharmaceutical Services (08/24/25)
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  • Assistant Director, GMP Quality Systems

    Kelly Services (Carlsbad, CA)
    …is instrumental in leading both internal and external audit programs with an emphasis on computer system validation (CSV) and data integrity audits. As a key ... & Clinical is seeking an Assistant Director, GMP Quality Systems for a direct hire opportunity with one of...+ Thorough understanding of domestic and international GMP regulations ( FDA , Eudralex, Health Canada, ICH, MHRA, MHLW, etc.). +… more
    Kelly Services (09/30/25)
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  • Senior Quality Systems Manager, Design…

    Medtronic (Boston, MA)
    …connected, compassionate world. **A Day in the Life** The Senior Quality Systems Manager drives the evolution of Medtronic's product development processes to set ... insights are incorporated into early design phases. + Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts… more
    Medtronic (09/25/25)
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  • Software Quality Engineer II

    Abbott (Sylmar, CA)
    …same. + Work with R&D and Manufacturing Engineering in the completion of system /software requirements and other verification and validation processes. + Create ... and execute or direct software validation protocols traceable to system /software requirements. Execute and support on-time completion of Quality Engineering… more
    Abbott (08/20/25)
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  • Process Engineer

    Colgate-Palmolive (Sanford, ME)
    …SAP, validation software (KNEAT), InBatch or similar plant/quality related computer systems . **Compensation and Benefits** Salary Range $79,200.00 - ... paced work environment. Preferred Qualifications: + A strong background in quality systems , validation , understanding of cGMP and 21 CFR 210 & 211, and… more
    Colgate-Palmolive (07/30/25)
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  • CQV Engineer Mid-Level

    Sokol Materials & Services (Skillman, NJ)
    …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up...AND RESPONSIBILITIES * Develop and execute commissioning, qualification, and validation protocols for equipment, facility systems , and… more
    Sokol Materials & Services (07/24/25)
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  • Building Engineer - Part Time

    ABM Industries (Carlsbad, CA)
    …Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + ... and validation , manufacturing and testing activities. + Serve as system administrator, maintain, troubleshoot, and program site trending and monitoring … more
    ABM Industries (08/07/25)
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  • Manager, Automation Engineering- Onsite

    AbbVie (Worcester, MA)
    …Operations, Quality, IT and Maintenance. + Manage and supports control system including standalone Manufacturing equipment, systems upgrades, data migrations ... Data Historian systems . + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP,...PI, Rockwell PLC are required. + Direct experience with system development and validation , including development of… more
    AbbVie (09/15/25)
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  • Embedded Software Engineer

    Abbott (Alameda, CA)
    …oversees the design, development, and validation of software for embedded systems , ensuring compliance with FDA requirements. They play a crucial role ... addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control… more
    Abbott (09/25/25)
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