CSV Engineer (Pharma)

Job Overview

Senior CSV Engineer/ Computer Systems Validation Engineer
Location: Cork

My client is a market leader in manufacturing solutions within the Biopharma & Pharmaceutical industries and they are looking for dedicated, innovative and driven talent to join their expanding teams.

You, undoubtedly, will be familiar with this client and their fantastic company reputation. They are also located in a beautiful part of the country, a short drive from Cork City.

Permanent position with excellent benefits package and career progression opportunities!


A little about the role…

  • As the Computer Systems Validation Engineer, you will work on large onsite projects for one of Ireland's most prominent Life Sciences manufacturing sites.
  • You will perform Automation Systems CSV at a Site Level for the Client and will be involved in Change Control generation, execution and close-out as well as prioritization of work to be completed. You and your team will be responsible for the validation of Lab Projects, working closely with the projects team on-site.
  • Monday-Friday, days role. This role will start ASAP (ideally)

Responsibilities:

  • Global and Site Change Control Impact Assessments
  • Automation Change Review and Approval
  • CSV Deliverables including 21CFR11 Assessments, Annex 11 Assessments, Business Criticality Assessments, GAMP Assessments
  • Review and Approval of Automation Designs
  • Testing Specifications pre-approval, review and post approval prior to progression to IOQ.
  • Rollout of Global initiatives, liaising with local site teams for implementation
  • Installation and Operation Qualification Protocol Generation, Execution and Reporting for PLCs.
  • Maintenance, Review and Approval of site Quality documentation e.g. SLIA, CLIA, System Descriptions, CSV Inventory List.
  • Co-ordination of changes to ensure timely delivery.


You will have the following…

  • Bachelors degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (Technology Management; Chemical Engineering)
  • 3-5+ years relevant experience in a CSV role, working on projects within GMP Biopharma/Pharmaceutical Industry
  • Experience working with Siemens PLC & WonderWare SCADA is an advantage
  • Familiar with SDLC based on GAMP 5
  • Data Integrity experience is essential
  • A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 11/ Annex 11 is essential.
  • Experience in writing validation documents e.g. Validation Plans, Requirements specs, Configuration specs, testing protocols, Change Controls, Vendor Management and Systems Validation
  • Experience of implementing systems in accordance with 21CFR Part 11 regulations i.e. Electronic Sigs & Electronic Records which also leads on to data Integrity & Audit Trail review.
  • Proven experience in the full Computer Systems Validation Life Cycle involving Validation Planning, Design & Configuration of software, Test Planning, executing testing, Traceability Matrix, Test Summary Report, Security Plan, Validation Report
  • Experience installing and working with PC controlled lab instruments (UPLC/HPLCs)
  • Excellent communication / interpersonal skills.


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Contact Dara Bradley or email your CV for more information and/or to review the full job spec. I would be delighted to guide you through the whole process..


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