Agenus

Computer Systems Validation Engineer

US-MA-Lexington
Job ID
2017-1303
Category
Quality

Overview

Quality Computerized Systems Validation Engineer (CSVE) ensures compliance of systems across the enterprise according to the applicable regulations and the Agenus Quality System, advises on related CSV quality matters, and assists in closing compliance gaps found during audits and inspections.

 

The position will be responsible for the authoring, executing, reviewing and approval of validation documentation deliverables and work with Quality to approve system release and implementation.

Responsibilities

The CSVE is responsible for:

  • Developing and executing CSV deliverables according to regulatory authorities for GxP computer systems to support commercial and development activities
  • Assess pre-existing GxP computer systems for compliance gaps and recommend solutions
  • Coordinate and/or perform all CSV
  • Provide guidance for CSV activities performed by contract service providers
  • Assess change controls for impact to validated computer systems
  • Participate in cross-functional Project teams to ensure business needs are met and implemented in compliance with associated predicate rules and governing regulations.
  • Pro-actively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices.
  • Builds and maintains trusting, collaborative relationships and partnerships with internal stakeholders which help accomplish key business objectives

Qualifications

Education & Qualifications

A minimum of Bachelor’s degree in Computer Science, Information Systems, or other related field is required. Any additional certifications are a plus. A minimum of 5 years of progressive responsible in GxP computer validation or other related experience is required. Experience in authoring or approving validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required. Strong QA analyst skills with experience in computer systems validation in GxP environments in the pharmaceutical industry are required. Expert project management and organizational skills is required. Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands is preferred. Must have the ability to work effectively in a highly matrix-ed global team environment is required. Demonstrated leadership capabilities are required. The ability to act as Project Lead in the development and implementation of processes and program is required. Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820, and EU Annex 11 is required. Demonstrates an understanding of GxP software options.  Demonstrated superior written and oral communication skills are required. Excellent skills with Microsoft Office are required. Knowledge of Quality Management process and Computer Systems Validation principles is preferred. Strong skills in interdependent partnering and influencing are required. The ability to find new ways to come to the same goal and pragmatic advising striving for the optimal solution ensuring compliance in a cost-effective way is required. Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality is required. Must have the ability to independently determine and develop approach to solutions and may determine long-term solution is preferred. Ability to manage multiple and competing projects is required.

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