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    Senior Engineer, Computer System Validation - Morrisville, United States - Ironshore Pharmaceuticals Inc

    Ironshore Pharmaceuticals Inc
    Ironshore Pharmaceuticals Inc Morrisville, United States

    2 weeks ago

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    Description
    Job Description

    Job Description

    Position Summary:

    The Sr.

    Computer Systems Validation (CSV) Engineer will oversee and participate directly in planning, developing, and executing validation activities for computerized systems according to regulatory requirements and data integrity standards.


    This role will provide guidance to cross-functional teams on CSV protocols as well as take an active, hands-on approach to managing and performing validation testing and documentation.

    The Sr. CSV Engineer will collaborate with IT, Quality, and other organizational units to align the validation approach with business needs.


    The position involves a balance of administrative and technical responsibilities including developing validation plans and strategies, authoring CSV documentation, ensuring adherence to regulatory guidelines, as well as conducting testing, troubleshooting issues, and providing hands-on subject matter expertise during system deployments.

    Strong working knowledge of CSV methodologies along with solid technical skills are essential for this dual-natured role. The Sr.

    Engineer will rely on experience with IT systems, data integrity, and quality processes to ensure compliance from both a strategic planning and hands-on execution perspective.

    *While our home office is located in Raleigh North Carolina, this position has the ability to be remotely based.

    Essential Responsibilities:

    Develop and Execute Validation Plans:

    Create risk-based validation plans and protocols for new and existing systems. Lead execution of system testing and qualification.

    Ensure Regulatory Compliance:


    Verify systems meet requirements of 21 CFR Part 11, EU Annex 11, data integrity guidelines, and other security, privacy, and regulatory frameworks.

    Provide CSV Expertise:

    Supply guidance, review, and thought leadership on CSV strategies, plans, issues to cross-functional teams and leadership.

    Conduct Assessments:

    Perform supplier, service provider, and periodic reviews of systems to maintain compliance.

    Lead Validation Projects:

    Provide leadership and subject matter expertise on IT implementation and upgrade projects requiring CSV.

    Collaborate with Stakeholders:

    Partner with Quality, IT, R&D and other organizational units to align validation with business objectives.

    Maintain CSV Documentation:

    Sustain up-to-date validation documentation, including trace matrices, test evidence, change control, and periodic reviews.

    Ensure Data Integrity:

    Confirm computerized systems meet data integrity principles and Part 11 requirements.

    Perform Hands-On Testing:

    Conduct system testing, troubleshoot issues, debug errors, and operate as part of implementation teams.

    Competencies:

    Technical/Professional

    Knowledge and Skills:


    Having achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise; leveraging expert knowledge to accomplish results.

    Adaptability:


    Maintaining effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusting effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful.

    Managing Work:

    Effectively managing one's time and resources to ensure that work is completed efficiently.

    Education, Skills, and Experience:

    Education

    :

    Bachelor's degree in computer science, engineering, or related field
    Skills:

    Expert knowledge of CSV regulations including 21 CFR Part 11, data integrity, and GAMP 5 guidelines.
    Hands-on experience with system development life cycles, quality processes, and equipment qualification.
    Proficient working knowledge of validation protocols and testing methodologies.
    Expert experience with quality management systems; Knowledge of computer system onboarding, evaluation, validation, and testing protocols.
    Excellent written and verbal communication skills for articulating CSV plans/results to diverse audiences.
    Strategic thinking abilities and business acumen.
    Exceptional attention to detail and project management skills to execute complex validation projects.
    Ability to manage multiple complex projects and priorities.
    Ability to anticipate regulatory needs and align validation approach with business objectives.
    Works closely with cross-functional partners in IT, Quality, R&D, etc. to achieve shared goals.
    Teamwork, collaboration, and stakeholder management aptitude.
    Experience:

    5+ years experience in CSV, quality assurance, or IT audit in a GxP environment
    Experience with quality management systems implementation and validation.
    Proven track record executing validation projects, leading testing, and authoring qualification evidence.
    Direct hands-on experience with system deployments, configurations, troubleshooting, and operation as part of implementation teams.
    Experience conducting risk assessments, gap analyses, data integrity reviews, and control testing.

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