Validation Engineer

PE Global
28 Sep 2016
20 Oct 2016
PEGlobal are looking for a Validation Engineer for our multinational medical devices client based in northern Scotland. Main Responsibilities of the role • Creation and execution of Validation plans and validation protocols for projects. • Prepare and /or revise validation protocols/procedures as required. • Review and execute qualification and summary reports, write and revise as needed. • Work under the confines of the project schedule and budget. • Analyse validation data, prepare reports, and make recommendations for changes and or/improvements. • Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity. • Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity. • Interface with Manufacturing, Mechanical and Controls Engineering group. • Have an understanding of PLCs and HMIs pertaining to validation activities. • Innovate and use good judgment to incorporate applicable standards and regulatory requirements. • Communicate ideas and comprehend information both verbally and in written form. • Follow all policy and procedures to maintain ISO9000 Certification requirements. • Prioritizes, plans, and organizes work and workspace. • Ability to travel (Europe or US) as required/agreed. Desired Experience and Skillset of the successful candidate Bachelor’s degree or Equivalent experience. Three to five years of directly related experience Technical understanding of medical equipment validation requirements Strong communication and interpersonal skills. Coordinates all validation activities by constant communication with affected departments and personnel. Knowledge of cGMP / Gamp5 requirements and current industry practices. Demonstrate ability to work in a cross-functional team environment. The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules. Strong knowledge of computer programs such as Windows, Excel, Word, Outlook and Project. Should have working knowledge of AutoCAD, Solid works and Rockwell – HMI programming environments. Experience in technical document writing with competencies in generating engineering based test cases across multiple disciplines (mechanical, electrical, controls and process). This job was originally posted as