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Thermo Fisher Scientific Senior IT Validation Engineer in Waltham, Massachusetts

The Sr. 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:

  • Provide compliance guidance to the IT function, business leaders, and stakeholders.

  • 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

  • Review and approve the relevant documents on validation processes

  • 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

  • Manage and execute decommissioning activities for retired or end-of-life equipment

  • Author/revise SOPs related to validation/qualification, operations, IT, as they relate to CSV

  • Represent Validation in cross-functional team meetings/projects as required

  • Effectively communicate with Leadership and all departments regarding Validation activities

  • Participate in conducting root cause analysis, deviation resolution (CAPA), and effectiveness checks for CSV

  • 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.

  • Analyze data outputs from CSV activities in order to determine acceptability of system for GxP business use. Recommends actions to be taken if the software is not accepted.

  • Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability, and ensure the organization employs appropriate risk based approaches to delivery taking into account the output of the supplier assessment.

  • 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 7 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

  • Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting regulated products.

  • Experience in the utilization of risk analysis tools such as FMEA

  • Experience in hosting/defending external audits and regulatory inspections

  • Ability to mentor junior CSV team members

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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