IT Validation Engineer

Thermo Fisher Scientific Frederick, MD

About the Job

Validation Engineer, Computer Systems

The IT Validation Engineer will independently review, comment and approve validation documentation including specifications, protocols, reports and SOPs with a focus on cGMP impact and validation lifecycle requirements and corporate IT Enterprise solutions. This independent role will lead the ITQA input on validation projects in support of IT delivered Quality Solutions. The candidate will provide direction to project teams on compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations. The ideal candidate will share ideas, discuss validation approach, communication of best practices, information sharing related to validation lifecycle e.g. Experience in the use of HP Quality center or other automated testing tools is desirable. The candidate will assist the business in areas of document management, IT policies and procedures.

Key Objectives of the Role:

  • Lead the development, harmonization, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
  • Preparation, review and issuing of CSV documents as they related to computer systems:
  • Author, execute, perform, summarize CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling
  • Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.
  • Identify computerized systems validation needs through assessments and integration with IT Project Management Framework.
  • Support change control activities, deviations and SOP’s for computer systems
  • Ensure that the Validation / Qualification and quality systems are working in accordance with any changing and current regulations.
  • Participate in the development of Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
  • Work closely with IT, Business, Regulatory Affairs, and Quality to develop, coordinate and execute Validation documents and strategies
  • Represent Validation in cross-functional team meetings/projects as required
  • Effectively communicate with Leadership and all departments regarding Validation activities
  • Organize and maintain validation documentation
  • Apply Good Manufacturing Principles in all areas of responsibility
  • Recommend acceptance of the computer system, as determined from the CSV tasks performed on the system.
  • Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the team and wider business.

Minimum Qualifications:

  • Bachelor’s Degree in Engineering, Science, or related field
  • Must have a minimum of 3-5 years experience in an FDA regulated industry
  • Through knowledge of cGMP and FDA and EU Annex 11 regulations and standards
  • Ability to impact and influence people/areas in matters related to CSV and GxP compliance
  • Use of HPALM a plus
  • Experience with Cloud compliance a plus