• Director of Validation

    Jabil (Hunt Valley, MD)
    …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more
    Jabil (12/11/25)
    - Related Jobs

  • Director, Commercial Manufacturing…

    Sumitomo Pharma (Annapolis, MD)
    …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
    Sumitomo Pharma (12/12/25)
    - Related Jobs

  • GXP Systems Analyst, Operational Technology

    United Therapeutics (Silver Spring, MD)
    …prioritize workload + Manufacturing or Quality system application support experience + Computer hardware / software validation and change control experience + ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
    United Therapeutics (12/11/25)
    - Related Jobs

  • Principal Member of Technical Staff - Medical…

    Oracle (Annapolis, MD)
    …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
    Oracle (11/25/25)
    - Related Jobs

  • Scientific Subject Matter Expert I

    Koniag Government Services (Silver Spring, MD)
    …regulatory applications and scientific reports, ensuring accuracy and completeness + Utilize FDA -provided Oracle or Access databases, or other computer systems, ... for data input as required + Perform data validation and quality control functions to maintain data integrity...+ Proficiency in using databases (eg, Oracle, Access) and computer systems for data input and management + Strong… more
    Koniag Government Services (11/12/25)
    - Related Jobs

  • Senior Controls Engineer, Operational Technology

    United Therapeutics (Silver Spring, MD)
    …and JCI Metasys experience + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + PLC ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
    United Therapeutics (01/09/26)
    - Related Jobs

  • NPD Eng I - Co-op

    Terumo Medical Corporation (Elkton, MD)
    …but is not limited to, the understanding of change control, validation , documentation practices, process control and design control requirements. 5. Contribute ... be to support product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. 2. Performs other job related… more
    Terumo Medical Corporation (12/17/25)
    - Related Jobs

  • Controls Engineer II, Operational Technology

    United Therapeutics (Silver Spring, MD)
    …procurement and utilization + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
    United Therapeutics (12/05/25)
    - Related Jobs

  • Regulatory Affairs Associate Director, IVD

    GRAIL (Annapolis, MD)
    …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
    GRAIL (12/03/25)
    - Related Jobs

  • Principal Engineer, Automation & Controls

    Terumo Medical Corporation (Elkton, MD)
    …oversee the Automated System Lifecycle definition, design, development, integration, and validation of new or modified manufacturing processes from concept through ... and production issues. d. Ensure all automation and control systems comply with FDA regulations, ISO standards, GMP requirements specific to medical devices and all… more
    Terumo Medical Corporation (11/12/25)
    - Related Jobs