Senior Automation Validation Engineer (CSV)
Our client, a major international Biopharma products producer is currently recruiting for a Senior CSV Engineer to join its Project team on a on a Green field site on a contract basis. Working at the our clients, North Louth facility
The CSV Engineer will be responsible for creation of bespoke validation packages complying with cGMP, regulatory requirements and site specific validation and quality-related procedures. This role, therefore, requires a technologically proficient professional with strong analytical and communication skills, who feels confident navigating through different systems and technical regulations.
* Excellent technical writing skills
* Good planning and organisational skills, ability to prioritise, work effectively on multiple tasks.
* Strong analytical and problem-solving skills.
Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
Support preparation of GxP Computerised System Lifecycle documents, including validation plans, requirements specifications, risk assessments, qualification protocols, requirements traceability matrices and validation reports.
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 to achieve objectives
Experience of PLC/Automation system validation.
Experience of Chrome and AxiChrome skids validation
5 years' experience working in the Life Sciences industry.
Bachelors or Master's degree in Engineering, Computer Sciences or related discipline.
Proficient with MS Office suite, with strong technical writing skills.
Ability to negotiate/compromise with other team members to achieve project goals
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).
B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required.
A qualification in project management would be advantageous
- Company Name
- Asset Recruitment Ltd
- Job Location