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Marquand

    Validation Engineer - Indianapolis, United States - PACIV

    PACIV
    PACIV Indianapolis, United States

    3 weeks ago

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    Description

    PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis).

    Job Description:

    The Validation Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets within our clients Biotechnology and Pharmaceutical sites. This support service will be performed working within the clients validation, project management, quality, and/or automation department team(s).

    Position Responsibilities/Essential Functions

      • Execute System Lifecycle deliverables from Commissioning and qualification (C&Q) and Computer System Validation (CSV) planning documents through System Retirement.
      • Actively participate among cross-functional teams and support project initiatives to ensure projects are delivered on time and to required quality standards.
      • Support execution of large product launches/releases, small capital projects, and process improvement changes related to the manufacturing and/or laboratory systems within the client site.

    Requirements

      • Bachelors degree and/or Masters degree in Engineering or Technical discipline required
      • 1 3 years of validation experience in the Pharmaceutical Industry
      • Comfortable with a 24/7 manufacturing environment
      • Works well with others within a team and takes accountability
      • Can handle a high-pressure, high-stress work environment
      • Result-driven and self-motivated
      • Strong interpersonal and communication skills (verbal and presentation)
      • Organized with strong computer literacy such as MS Word, Project, Excel, etc.

    Desired Hard Skill Sets (via Internships/Co-Ops):

      • Familiarity with Validation principles and executable deliverables (i.e. Requirements, Design, Testing, Reports, etc.)
      • CSV experience, ideally around Data Integrity and CFR Part 11 Electronic Records and Signatures
      • Project Management experience with the ability to lead and drive projects to completion autonomously

    Other Requirements

    Location: Indianapolis

    Travel: Up to 20% of the time to various suppliers, collaborators, and client sites outside of Indianapolis

    Compensation:

    Competitive Salary and Benefits Package, which includes:

    • Paid Time Off (PTO) for vacation, sick, and company holidays
    • PTO is earned on an accrual basis throughout the calendar year.
    • Health Insurance
    • PACIV pays 90% of the premium for the health insurance plan. Monthly contributions made by PACIV and are distributed through an HSA (Health Savings Account)
    • $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the team members cost.
    • 401(k) Retirement Plan with company match
    • Project Performance Bonuses (for qualified projects and employees)
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