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    Senior Validation Engineer - Bedford, United States - a Medical Devices company in MA

    a Medical Devices company in MA
    a Medical Devices company in MA Bedford, United States

    3 weeks ago

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    Description

    RESPONSIBILITIES
    Continuously improving the design of automated systems, execution, and automation processes.
    Collaborating effectively with Process Engineering, Operations, Quality, and Validation departments on an ongoing basis.
    Communicating automation-related issues and providing recommendations based on discovered issues.
    Creating a sustainable automation framework for large-scale, highly integrated applications (PLC-based, DELTA V system, PC-based, OSI-PI).
    Providing thought leadership on automation system architecture and offering guidance on application design and development for enterprise-wide scalability.
    Aligning with existing design/development/usage of automation frameworks and technologies.
    Working with the development team and/or vendors to successfully integrate automation systems.
    Leading and mentoring other engineers in Automation design, Implementation, and Validation.
    Planning networking architecture and collaborating with the IT group or Consultants.
    Conducting and supporting FAT (Factory Acceptance Test), SAT (Site Acceptance Test), IQ (Installation Qualification), and OQ (Operational Qualification).


    QUALIFICATIONS
    Minimum 10+ years of experience in software design, development, or code review.
    Minimum 3+ years of automation engineering experience in the biopharmaceutical industry.
    GMP experience, change, and deviation management experience required.
    Ability to lead assigned work groups, prioritize assignments, and provide technical/development guidance.
    Proficiency with PLC-based systems, DELTA V, PI, SQL.
    Experience working in a regulated GMP environment.
    Ability to work both in a team and with individual assignments.
    Strong evidence of leadership and initiative-taking is desired.
    Experience supporting batch and continuous industrial control systems.
    Knowledge of equipment integration, commissioning, and validation.
    Development, preparation, and execution of comprehensive test plans, procedures, and schedules for systems.
    Experience with Reliability Centered Maintenance systems.
    Experience with a start-up or Greenfield site.
    Coaching and facilitation skills.
    Ability to manage multiple priorities.
    Strong communication (verbal/written), organizational, and interpersonal skills.
    Ability to work independently or as a team player.
    Ability to work through peers and across organizational boundaries and influence at all levels in the business.
    Efficient use of current computer packages, particularly Excel, PowerPoint, MS Project, and Word.


    EDUCATION
    Bachelor's degree in Computer, Electrical, Chemical, or a related engineering discipline.

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