Website Asset Recruitment
Senior Automation Validation Engineer (CSV)
Our client a major multinational Biologics manufacturer 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 on site at their state of the art Biologics, facility in Dundalk the CSV Engineer will be responsible for creating 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, that feel confident navigating through different systems and technical regulations.
• Excellent technical writing skills
• Good planning and organisational skills with the ability to prioritise, work effectively and independently 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 the 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 computer systems and 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
• 5 years’ experience working in the Life Sciences industry.
• Bachelors or Master’s degree in Engineering, Computer Sciences or related discipline.
• Experience of Chrome and AxiChrome skids validation
• Experience of PLC/Automation system validation.
• 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.
Good To have:
• Demonstrable understanding of GMP and CSV experience in the Life Sciences industry.
• 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.