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We wish to recruit a Validation Engineer for a client based in Dublin

Job Title: Validation Engineer

PM Group wish to recruit a Validation Engineer for a client based in Dublin.  The roles requires the 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.

Key Responsibilities

  • 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

Qualifications and Experience

  • 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

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

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Validation Engineer DU19144 - DU19144

Dublin, Ireland

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