CSV Engineer

Pe Global

Galway

Working with Equipment Engineering , the successful candidate will assist R&D and Operations on New Product Development Programs and Sustaining Programs by participating on the Design, Build, Commissioning and Qualification of New Equipment as well as Equipment Upgrades. The Role is primarily based in Galway , a World Class Facility, although traveling abroad may be required from time to time and for short periods. Working times are Monday to Friday; however Weekend work may be required. 10. Job Duties: Participates and Leads the use of lean and Continuous Improvement tools in equipment designs and engineering systems. Works closely with the customer to understand requirements and propose creative and cost effective solutions. Generates quotations, concepts and business cases for new and upgrade equipment. Ensures Equipment requests are processed in a timely and effective fashion and manage execution of results. Determines Project schedules and works with team and other departments across the plant to ensure adherence. Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage. Prepare software design specifications and associated documentation for equipment and systems. Ensure software is controlled and stored as per validation procedure guidelines. Work with Quality department to ensure equipment validations are in line with plant validation standards. Ensure regulatory compliance with European and US software validation requirements. Ensure Computerised system validation procedure(s) is (are) kept up to date and maintained. Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment. Provides software validation/compliance guidance and training to staff across various functions as required. Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organisational issues. Ensure best validation practices are employed by the Equipment Engineering Group so as to maximise effectiveness and minimise non-value added work. Creates and executes IV/OT documents and reports, reviews FS's and provides direction and support on validation plans. Actively pursues continuous improvement. Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects. JOB REQUIREMENTS & SKILLS. 11. Minimum Years of Proven Experience on a similar role: 4+ 12. Minimum qualification level (Irish NFQ or equivalent): Level 7 - Ordinary Bachelor Degree. 13. Job Required Skills (Proven experience required) : Excellent analytical, system analysis and problem solving skills; Has the ability to acquire new skills quickly and thrives in a fast paced, collaborative team environment. Excellent written and verbal communications skills. Ability to recognize exceptions to documented policy and procedures. Ability to monitor schedule deviations and assist in the development of alternative methods for corrective action at the project level. Experience working in a regulated industry. 14. Job Extended Skills (these Skills are not Required but will be considered) : SQL development and knowledge of Microsoft SQL Server. This job originally appeared on RecruitIreland.com.

2444 days ago