NRL are currently recruiting on behalf of our Irish client for a Senior CVS Engineer. The role will be based in Dublin.
Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirements specifications, risk assessments, qualification protocols, requirements traceability matrices and validation reports.
Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
Perform business analysis activities.
Ensure that computer systems and its associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
Plan, organise and prioritise own workload and assist other team members in doing so, in order to achieve agreed objectives and ensure all relevant deadlines are met.
Be supportive and encouraging of others in the team, showing flexibility in the delivery of team results. This may from time to time involve working outside normal working hours in order to achieve defined objectives
Experience working in the Life Sciences industry.
Experience of Chrome and AxiChrome skids validation
Experience of PLC/Automation system validation.
Bachelors or Master's degree in Engineering, Computer Sciences or related discipline.
Proficient with the Microsoft Office suite, with strong technical writing skills.
Ability to work well with diverse, multi-disciplined groups, being respectful to fellow team member's ideas and opinions.
Ability to negotiate/compromise with other team members to achieve project goals.
The following experience would be strongly advantageous:
Candidates that can demonstrate understanding of Good Manufacturing Practices (GMPs) and CSV experience in the Life Sciences industry will be preferred.
Experience with good practices for GxP computerised systems (GAMP5) and database systems.
Knowledge of GxP regulations (including but not limited to Eudralex Volume 4 chapters 11 and 15, 21 CFR Part 820 and 21 CFR Part 11).
Knowledge of industry guidance and project management skills.
B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required.
A qualification in project management would be advantageous.
What’s in it for you:
Competitive hourly rates
Stable contract duration
Opportunity to support a wide range of projects with a large engineering consultancy