Full Time Contract

Application Closing Date: 01/07/2021

CSV are 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 client facility the 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.

Key Skills:

• 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.

Main Responsibilities:

• 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.

Essential Criteria:

• 10 years’ experience working in the Life Sciences/pharmaceutical industry, acting as CSV role.
• Familiar with upstream equipment (ATF/Bioreactor)/downstream (e.g. AKTA,AxiChrome, DF/VF, etc) CSV is a plus
• Experience of EMS/PI system validation is a plus.
• Experience of PLC/Delta V/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.

Desirable Criteria:

• 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.

CSV Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit.