• CSV Analyst

    Job Post Information* : Posted Date 1 month ago(4/20/2018 11:26 AM)
    ID
    2018-8075
    # of Positions
    2
    Work Location (City/State)
    Mahwah, NJ or Fairfield, NJ
  • Who We Are

    GalaxE.Solutions

    Every day, our solutions affect people throughout the world. From Fortune 100 companies to start-ups, GalaxE develops and implements strategic projects that are critical to the success of customers’ businesses and the lives of tens of millions of people.

     

    For over twenty-five years, we have grown and evolved into a multi-national firm that employs over 2000 team members worldwide. But we’re not done evolving. It took collaboration and innovation to get here, and it takes collaboration and innovation to get where we (and our customers) want to be tomorrow.  

     

    What does this mean for our employees? They have the security of an established company, with the benefits of working for a company where great minds, hard work, leadership and innovation are highly regarded and rewarded.

     

    As Thomas Edison said, “There’s a way to do it better – find it”. We want our employees to find it.

     

    We’re looking for creative people, with an entrepreneurial spirit, looking to work on awesome projects! Sound like you? Come work with us! Find out for yourself what it means to be part of the GalaxE team.

     

    It’s not always easy, but important work never is. #WeAreGalaxE

     

    Equal Opportunity Employer/Veterans/Disabled

    What You Will Do

    • Perform validation of computer and automation systems ensuring compliance to required regulatory requirements.
    • Partner with the Global IT Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation and Compliance
    • Deliver validation activities in compliance with US and EU regulations.
    • Participate in the design of systems and equipment, if needed, to ensure that they comply with GMP/GCP/GLP requirements.
    • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
    • Initiate and implement change control activities in accordance with site procedures.
    • Compile and analyze validation data and make recommendations for improvements.
    • Participate on cross-functional project teams with the support of Validation activities.
    • Author relevant validation documentation (e.g. Master Plans, Test Scripts, Templates, etc.), as defined by the Client's IT SDLC methodology.
    • Execute all relevant validation protocols and test procedures, as defined by the Clients' IT SDLC methodology
    • Develop validation documentation as required (e.g. specifications, user requirements, plans, protocols, procedures, traceability matrix, error/defect reports, etc. ).
    • Execute qualification protocols as required.
    • Prepare reports of executed protocols for review by QA.
    • Track and resolve exceptions during qualification activities.
    • Proactively resolve conflicts between compliance requirements and project/business constraints.
    • Co-ordinate validation activities with IT, Business, QA activities.

    Skills and Experience You Will Need

     

    Required:

    • 4-6+ Years: Computer System Validation
    • 2-4+ Years: BIO/Pharmaceutical industry experience
    • Experience with equipment controlled by ERP, LIMS, EMS, PMS, and other Quality and Development Laboratory systems.
    • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, Part 820, and GAMP standards are required.
    • Process Validation – CQA – Calibration, Manufacturing Equipment Software Validation
    • Must understand Manufacturing Line and Operational Excellence in Production Environment utilizing Software that validates equipment
    • Root cause analysis; experience investigating and troubleshooting automation and control systems
    • Background in Engineering
    • Ability to work in cross-functional team environments, as well as independently, and to work multiple and competing projects
    • Strong written and verbal communication skills
    • Knowledge of MS Office, SharePoint, MS Project, and Visio.
    • Must be local - Face to Face interviews are required

    Desired:

    • Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.
    • International, cross culture, and cross functional experience desired
    • Project management skills
    • ISO-13485:2016 knowledge and experience

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