CSV Engineer

The CSV Engineer reports to the Engineering Services Manager and will participate in:

• All Computerised System Validation (CSV) activities on site, along with periodic re-qualification requirements.
• Provide CSV support to capital projects that are executed on site.  

The role requires a thorough understanding and experience of the validation requirements associated with a pharmaceutical manufacturing facility.

RESPONSIBILITIES:

• Support the CSV requirements for site production and laboratory systems.
• Support the management of ongoing CSV re-qualification requirements. 
• Work cross functionally to develop and deliver the annual CSV re-qualification requirements.
• Provide CAPEX team with adequate validation support at all times.
• Review vendor documents to support commissioning and qualification requirements.
• Completes the development, review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
• Ensures validation non-conformances or deviations are minimised during execution of CSV activities. For issues that do arise ensure they are closed out in a timely manner.
• Supervise vendors/ contractors on site as required.
• Ensuring compliance with current industry regulations and guidelines relating to validation.
• Support department performance against defined KPIs.
• As required. support the Technology Transfer initiatives for incoming new products.
• Participate in the control of Safety and Environmental programmes.  Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
• Encourage actively the culture of teamwork and integration within the Engineering Services Department, and with all other Departments.
• Participate fully in cross-functional training initiatives.

GENERAL RESPONSIBILITIES:

• Participate fully in any cross functional training initiatives.

• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
• Ensure timely completion of all SOP, reading, training and assessment.

• Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:

• 3rd level Engineering or Science Degree, or equivalent