Website Asset Recruitment
Senior CSV Engineer
Our client is currently recruiting for a Senior CSV Engineer to join its Project team at their green field site. This is a long-term contract and the successful candidate will be based on site at our clients advanced technology Biologics Dundalk facility. The Senior CSV Engineer will be responsible for the creation of bespoke validation packages that comply with current good manufacturing practices, 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.
· Good planning and organisational skills with ability to prioritise, work effectively and independently on multiple tasks.
· Excellent technical writing skills
· Strong analytical and problem-solving skills.
· Support 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.
· 10 years’ experience working in Life Sciences/pharmaceutical industry, within CSV.
Familiar with Upstream Equipment ATF/Bioreactor/downstream -AKTA, Axi Chrome, DF/VF
Experience of PLC/Delta V/Automation system validation.
· Experience of EMS/PI system validation is a plus.
· 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.
· Experience with good practices for GxP Computerised Systems (GAMP5) and database systems.
· Candidates that can demonstrate understanding of Good Manufacturing Practices CSV experience in the Life Sciences industry preferred.
· 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.