Validation Engineer III - Portsmouth, United States - Mindlance

    Mindlance
    Mindlance Portsmouth, United States

    4 weeks ago

    Mindlance background
    Description
    This role is a senior CSV engineer requirement.


    • CSV /Automation experience of 5+ years
    • Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / Client (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
    • Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
    • Experienced at working independently as well as in a team-oriented, collaborative environment is essential
    • Author, Review, Approve and Execute CSV life cycle documentation
    • Experience working with and programming/commissioning/validating Delta V software platforms
    • Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems
    • Manage, document, and assess the software changes throughout the SDLC following Lonza procedures.
    • Knowledgeable of S88 Batch Standard is preferable
    • Recipe management DeltaV software development and testing is preferable
    • MES Recipe authoring and testing is preferable
    • Implementation and validation of QC system is preferable
    • Experience with Kneat is preferable
    • Strong verbal and written communication skills
    • This role is 100% onsite.

    EEO:
    "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."