Validation Engineer

CSV / Serialisation / Aggregation    Reference:  TPS112
SALARY Negotiable   LOCATION Ireland, Dublin
JOB TYPE Contract (12 months) / Staff   DATE POSTED 05/07/2019
INDUSTRY pharmaceutical      
         
DESCRIPTION        
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.

 

Charlie Burgess +442081236574 Agent UK & Ireland