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Staff Validation Engineer (Computer Systems Validation)

Company: Thermo Fisher Scientific Inc.
Location: Greenville
Posted on: May 6, 2021

Job Description:

Job Description When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. How will you make an impact? The Staff Validation Engineer (CSV) will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV) and Lifecycle procedures, and Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems. The incumbent will provide the necessary oversight of system related issues, employ risk-based methodology, and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Additionally, the individual will focus on ensuring consistent policy administration, implementing key improvement initiatives and solving compliance issues. What will you do?

  • Serve as a principal technical expert in regards to validation activities associated with equipment, computers, and processes.
  • Serve as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.
  • Lead multiple complex validation activities associated with computers, equipment, and processes.
  • Develop and execute validation plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs.
  • Coordinate validation associated audit activities; establish rationales and technical defense positions.
  • Negotiate with clients the validation requirements for projects. Resolve significant validation, product and regulatory issues. Plan and establish technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.
  • Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.
  • Participate as the validation representative in project team activities and process design to insure CGMP compliance and interdepartmental consistency within the validation program.
  • Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
  • Maintain current knowledge and serve as a technical resource for emerging trends and technologies.
  • Coordinate and provide training and/or opportunities for career development of others.
  • Perform other duties as assigned. How will you get there?
    • BS/BA in a scientific or production related discipline plus 6 years experience in the pharmaceutical industry to include 2 years validation experience.
    • AA/AS in a scientific or production related discipline plus 7 years experience in the pharmaceutical industry to include 2 years validation experience.
    • 8 years experience including 2 years validation experience.
    • Broad based knowledge of regulatory compliance requirements related to validation and relevant production controls.
    • Strong interpersonal and communication skills. Ability to effectively collaborate with others to achieve team goals and expectations. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today!

Keywords: Thermo Fisher Scientific Inc., Greenville , Staff Validation Engineer (Computer Systems Validation), IT / Software / Systems , Greenville, North Carolina

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