Client: Engineering company delivering system integration in the area of industrial automation in Ireland. Office based in Grangecastle. Offers a full spectrum of related services including system development, upgrades, technical support, project management and validation consultancy.
Role Summary: Validation Engineer to have CSV knowledge and the ability to manage the validation of a packaging serialisation & aggregation project. The role is at equipment and systems interface level primarily dealing with validation of line level equipment and interfaces to corporate SAP level.
Role Requirements: The chosen candidate would typically be accountable for the following activities (but not exclusively);
- Use knowledge of FDA cGMP and related regulations and guidelines and specific knowledge of validation methodologies and principles to perform validation on a variety of systems.
- Co-ordination of site validation activities as per corporate Software Development Lifecycle and internal Quality Management systems.
- Lead the project validation stream for the relevant projects.
- Validation of line level UPI equipment.
- Validation of SAP <-> MES (Manufacturing Execution Systems) interface.
- Validation of Serialisation and Aggregation Solution <-> SAP interface.
- Validation of Downtime Management System (DMS) -> SAP interface.
- Preparation, review, execution and approval of validation documents and associated deviations/NCRs for computerised systems.
- Analysis of results of testing and determining acceptability of results against predetermined criteria.
- Computer systems validation.
- Ensure compliance with current industry regulations and guidelines relating to validation.
- Advise and support project team on computer validation activities.
Qualification & Requirements
- Third level Degree in a relevant discipline.
- Minimum of 5 years’ validation experience in the Pharma sector.
- CSV experience is desirable.
- Experience of QA in a FDA regulated environment also desirable.
- Project planning experience a distinct advantage.
- Past experience writing, reviewing and executing validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).
- Good understanding of Production Applications (e.g. MES, LIMS) with focus on interfaces.
- Experience with SAP is a plus.
- Experience with validating serialisation/aggregation solutions is an advantage.
- Experience in risk assessments in relation to validation activities.
- Technical writing experience.
Get in touch with us for full brief on this position.