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CSV Engineer

Job description

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. 

Job Responsibilities

  • Support the CSV requirements for site production and laboratory systems.
  • Support the management of ongoing CSV re-qualification requirements.
  • The CSV Engineer will work cross functionally to develop and deliver the annual CSV re-qualification requirements.
  • Provide CAPEX team with adequate validation support
  • 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.
  • As required. support the Technology Transfer initiatives for incoming new products.
  • Participate fully in cross-functional training initiatives.

 

Job Requirements:

The next CSV Engineer should have a 3rd level Engineering or Science Degree with at least two years validation experience (CSV) within a pharmaceutical setting.

Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.

Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines would be an advantage.

 

If you’re looking to join one of Ireland most exciting biopharma start-up facilities then get in touch now to hear more!

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