Computer Validation Engineer II

Primary Role:

This position is responsible for supporting Shire HGT's computer validation program. Primary resposibilities include the generation and field execution of validation protocols, and the reporting of validation results. The position will work closely with senior validation engineers and internal customers to support the validation of Automated manufacturing systems, Laboratory analytical instruments as well as Global Information Systems, including infrastructure components and platforms.

Responsibilities:

Develop validation protocols, execute validation studies, perform data analysis, and compile data and results into final reports. (60%)

Review computerized systems design documentation; develop appropriate testing strategies to ensure confidence in the system's ability to meet intended-use requirements. (15%)

Review proposed changes to qualified systems and associated IT infrastructure components to identify the validation requirements necessary to maintain the system's validation status. (10%)

Train both internal and contract personnel, as necessary, who may be utilized to execute individual validation protocols. (5%)

Support other computer system validation activities (CSV Procedure update and development, CAPAs, Projects, etc.) (10%)

Education and Experience Requirements:

Requires B.S. in a technical Discipline with a minimum 3-5 years validation experience or M.S. with 2-4 years validation experience.
Preference given to candidates with experience utilizing GAMP5 and/or direct experience with any or each of the following:
Automated manufacturing systems validation, Laboratory analytical instruments validation, Global Information Systems validation.

Key Skills and Competencies:

This position requires excellent organizational and communication skills, attention to detail, and a thorough knowledge and understanding of FDA and foreign (EU, Canadian) validation, requirements and expecations. This position also requires knowledge of GAMP 5, Risk Management, and 21 CFR Part 11.

The incumbent must be self-motivated, able to correctly set his/her own priorities to simultaneously manage multiple projects and meet project deadlines.

Complexity and Problem Solving:

The incumbent will be involved in a wide range of complex problems, which require the regular use of ingenuity and creativity, working with some direction, but provided latitude to determine assignment objectives. He/she may propose alternative methods and procedures to be used on new assignments. Completed work is reviewed from both a short term and long term perspective for desired results.

Internal and External Contacts:

This position will have frequent contact with management, internal customers, and outside contract/vendor professionals and will act as the validation lead on projects.
While this position has no direct reports, it is expected to provide guidance or oversight to vendor personnel

Other Job requirements:

Travel to other Shire locations and to vendors may be occasionally required.