Computer System Validation Engineer
Job Title: Computer System Validation (CSV) Engineer
Contract: 12 Months
Location: Cork, Ireland
The CSV Engineer performs activities to support the computer systems commissioning and qualification and subsequent validation in a new Bulk Drug Substance manufacturing facility.
The successful applicant will develop and contribute to Project Lifecycle and Test documentation and will also assist in the execution of testing for the plant in line with agreed timelines for this key capital project.
The role is a contract position as part of the Automation / MES Team.
- Automation Design, Commissioning, Qualification and Validation documentation - drafting, reviewing and approving CSV related elements of documentation as appropriate.
- Co-ordinate and execute CSV related commissioning, qualification and validation activities where applicable.
- Accountable for scheduling, tracking, reporting and achieving project deadlines.
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Actively contribute to project teams.
- Attends Departmental and Team meetings focused on CSV activities.
- Serve as a CSV representative for internal technical group discussions.
- Understanding and applying industry specific compliance standards/regulations to all Commissioning/Qualification activities.
Education / Qualifications
- Degree level qualification in Science or Engineering or equivalent.
- Commissioning, qualification and validation experience in vaccine or sterile product manufacturing and building management would be an advantage (min 3 - 5 years)
- Strong technical writing and communication skills.
- Ability to close items to completion.
- Ability to work with a high level of detail and to a high standard.
- Experience with ISA S95 and S88 standards.
- Experience in the implementation of a risk based validation approach as per ASTM E2500- Preferred but not required.
- Experience with MES Systems - preferred but not required (Werum PasX, Emerson Syncade, etc.).
- Experience with Process Control & Building Management Systems - preferred but not required (DeltaV, Siemens, Allan Bradley).
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales