Job Title
Senior Computer Systems Validation Engineer – Lab Systems


Location: Dublin
Contractor Opportunity

As a Senior CSV  Engineer for Lab Systems you will be responsible for a specific new system implementation project. You will challenge a record evidence of compliance to ensure compliance with FDA 21 CFR Part 11 regulation. The role will focus purely on computerised system validation and data integrity and security.

Responsibilities

  • Managing and co-ordinating the preparation, review and approval of the Validation Master Plans
  • Managing and co-ordinating of all validation strategies and deliverables
  • Development and maintenance of internal validation policies and procedures based on best international standards and practices
  • Auditing of internal projects against internal validation policies and procedures
  • ERES and data integrity testing
  • Media and Backups
  • Test set up
  • Configuration Tests
    • Computer Hardware and Software verifications
    • Windows security verifications
    • User privileges management and control
    • User review management
    • Backups configuration and verification
    • Electronic Signatures – Confirm the eSignature configuration are defined, approved and configured correctly on the system
  • Functional Testing
    • Logon security management
    • User account management
    • Data security and management of critical electronic records
    • Management of the audit trail
  • System upgrade tests
  • Control and management of legacy data
  • Tests wrap management and reporting
  • Develop and implement OQ on standard compliance tests
  • Develop process data map for systems in conjunction with quality function
  • Risk assessment for online data review
  • Continuous improvements via review process

Requirements

  • Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline.
  • Over 5 years’ experience as a Computer Systems Validation Engineer (mainly lab systems) in the Pharmaceutical or related Healthcare industry
  • MES experience
  • Experience of GxP Computerised Systems
  • Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements
  • Familiar with the GAMP5 guidelines
  • High level of knowledge of FDA 21 CFR
  • Excellent communication skills, including ability to advise and influence
  • Excellent attention to detail
  • Excellent understanding of validation concepts and documentation.
  • Excellent communication skills, including ability to advise and influence.
  • Should be based within a commutable range or else willing to re-locate
  • Some of this role will be onsite and some can be carried out remotely depending on project requirements

Why Choose This Role & SL Controls

  • An excellent compensation package which rewards high performers
  • The opportunity to work clients who are global leaders in their field
  • A supportive environment committed to employee development and wellness
  • The opportunity to work with, help develop and improve upon industry leading technology solutions
  • A collaborative and open culture where you are valued and can contribute to company initiatives and growth

About SL Controls

SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets. Over the past 16 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Dublin and Florida. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.

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