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Computer Systems Validation - Lead

Company: Thermo Fisher Scientific
Location: Albany
Posted on: November 26, 2022

Job Description:

When youre part of the team at Thermo Fisher Scientific, youll 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 youll be supported in achieving your career goals.How will you make an impact?A Computer Systems Validation Engineer is expected to lead and orchestrate the key quality processes pertaining to Projects delivery and operations track, governed through various Thermo Fisher Scientifics Corporate Quality Policies, procedures, work instructions, forms and templates in line with GxP Regulations, GAMP5 guidelines and Government Regulations (like 21 CFR part 11, 210, 211, 820, ISO 13485 and EU Annex 11 etc.). CSV responsibilities start from the inception of a project and goes up to go-live phase and maintenance of a computerized system in a validated state. Validation engineer position offers a challenging opportunity for a dedicated engineer to implement new technologies and develop the best Validation practices in a growing organization.What will you do?

  • Drafting and approval of VAL Plan and Summary Reports for Projects and Change Management
  • Review and approve Project requirements (URS, FRS, SRS, Data Migration Requirements), protocols (pre and post IQ, OQ, PQ, DMQ), Defects management in various GxP critical environments
  • CHG Maintenance post go-live, periodic reviews and ensuring the project stays in a fully validated state from Regulatory and Compliance perspective
  • Qualification/Validation of tools/utilities interacting with GxP sensitive environments
  • Executing CAPA procedures, drafting and approving deviation logs and keeping artifacts audit-ready in MasterControl, ALM and Service Now tools. A sound knowledge of QMS tools like MasterControl, HP ALM and CHG Management tool Service Now is helpful.
  • Review and draft standard operating procedures for tools refresh, upgrades, patching etc.
  • Coordinating with partners for configuration and design specs update and overall Project CHG managementHow will you get here?
    • Bachelors Degree in Engineering, Science, or related field. In lieu of a bachelors degree, at least 4+ years of professional experience required
    • Must have a minimum of 3+ years of experience in an FDA regulated industry, preferably on One Maximo Calibration system
    • This position is intended for Global Validation work so any proven experience in ERP systems or Lab systems would be a definite plus
    • Thorough knowledge of cGMP, FDA, CFRs, ISO, Regional and EU regulations and standards
    • Ability to impact and influence people/areas in matters related to CSV and GxP compliance
    • Use of HPALM and MasterControl a definite plus
    • Experience with CHG Management over Service Now a plus
    • A minimum of 3+ years of experience working in a FDA regulated Pharma industry/organization
    • 5+ years of Experience over project delivery methodologies (like PMO, Software Testing, Development, Business analysis of IT applications), operations track (CHG Management), maintenance/support work, a thorough knowledge of SDLC is a must.
    • 4+ years of Experience over SAP or other ERP Systems would be a bonusKnowledge, Skills, Abilities
      • 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 and 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 essential team members to achieve business goals.
      • Identify computerized systems validation needs through assessments and integration with IT Project Management Framework.
      • Support change control activities, deviations and SOPs for computer systems
      • 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
      • 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.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, Albany , Computer Systems Validation - Lead, IT / Software / Systems , Albany, New York

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