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Job Description
Summary: The CSV Engineer role involves participating in Computerised System Validation activities, providing CSV support to capital projects, and ensuring compliance with industry regulations and guidelines. Responsibilities include supporting site production and laboratory systems, managing ongoing CSV re-qualification requirements, and developing and delivering annual CSV re-qualification requirements.
Key Responsibilities:
- Support site production and laboratory systems
- Manage ongoing CSV re-qualification requirements
- Develop and deliver annual CSV re-qualification requirements
- Review vendor documents to support commissioning and qualification requirements
- Complete validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports
- Ensure validation non-conformances or deviations are minimised during CSV activities
- Supervise vendors/contractors on site as required
- Ensure compliance with current industry regulations and guidelines
- Support department performance against defined KPIs
- Encourage teamwork and integration within the Engineering Services Department
Requirements:
- 3rd level Engineering or Science Degree, or equivalent
- At least three years validation experience (CSV) within a pharmaceutical setting
- Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility
- Experience with regulatory audits, in particular representing computer system type issues
Benefits:
- Transforming patient care through novel specialty pharmaceuticals
- Employee-focused workplace with opportunities for growth and development
- Inclusive, collaborative culture with a commitment to diversity and equality