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Senior Validation Engineer

Company: Verista
Location: Zionsville
Posted on: June 25, 2022

Job Description:

DescriptionLooking for an exciting opportunity at a fast growing, employee-oriented company? Verista's 500+ experts team up with the world's most recognizable brands in the life science industry to solve their business needs. Whether it's compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.Verista's experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, we're uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day.We deliver solutions that are right the first time.Typical Responsibilities Include:

  • Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.
  • Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
  • Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
  • Manage and work collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
  • Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.THIS POSITION IS INTENDED TO SUPPORT CLIENT COMPANIES THROUGHOUT THE UNITED STATES. CANDIDATES CAN BASE ANYWHERE IN THE US IF THEY ARE OPEN TO TRAVEL AS NECESSARY. Requirements
    • A minimum of a bachelor's degree in an Engineering or Scientific degreePreferred:
      • 3+ years' experience in GMP regulated environment
      • Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls)
      • Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
      • Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment
      • ASTM-E2500BenefitsBecause employees are the key to our success, Verista offers strong benefits and incentives including:
        • Health, Dental, and Vision Insurance
        • 401(k) Retirement Plan with a company match
        • Paid Time Off Pay
        • Tuition Reimbursement
        • 9 Company Paid Holidays
        • Paid Long Term & Short Term Disability Insurance
        • Training and Development
        • Paid Maternity Leave and Parental Leave
        • Travel Bonus
        • Employee Referral Program
        • Tuition Reimbursement
        • Marriage Leave
        • Bereavement
        • Verista is an Equal Opportunity Employer

Keywords: Verista, Fishers , Senior Validation Engineer, Engineering , Zionsville, Indiana

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