Computerised System Validation Engineer required to support CSV activities for growing medical devices company in Galway.
You will support CSV activities for our client’s manufacturing and laboratory equipment, business and quality management systems. Utilising your knowledge of manufacturing and laboratory equipment, you will have the opportunity to write/review software lifecycle documentation, while writing software code and code testing/automation testing are not part of this role.
Requirements:
- Bachelor or Master’s Degree in Science, Computer Science, Engineering or Quality Assurance
- Minimum of 1-2 years’ experience working in a regulated medical device or pharmaceutical company in CSV or Process Validation or Equipment Validation or Calibration roles.
- Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Parts11 & 820.
- Familiarity with GAMP5 Guideline for ‘Risk Based approach to GxP Compliant Computerised Systems.
- Some knowledge of Computerised System architecture.
- Ability to work within a team environment to achieve agreed company goals.
- Communicate effectively with all levels of the company.
- Ability to meet deadlines and follow through on assigned deliverables.
Responsibilities:
- Support and lead Quality and Compliance activities in relation to CSV activities.
- Author CSV documentation; user requirements specifications, test scripts, protocols, reports, etc.
- Quality reviewer on all CSV and system supporting documentation.
- Support, guide, and monitor projects to ensure that approved software development standards, processes, and procedures are adhered to, while also guiding the adoption of industry best-practices.
- Support Computerised System Change Control process.
emer@emtechrecruitment.ie
