Computer Systems Validation Engineer Role Limerick

Computer Systems Validation Engineer

  • Posted Last Week
  • Limerick
  • Contract
  • BBBH27539

LSC have a great contract opportunity for a Computer Systems Validation Engineer to join an innovative and rapidly growing Biopharmaceutical company in Limerick. The facility is responsible for the production, packaging, labelling and delivery of biopharmaceutical medicines for global markets. The company currently markets medicines for various diseases and has a rich pipeline of products.

Purpose:
This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems.
Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities

  • Prepares/reviews validation documentation related to projects/change controls.
  • Manages change controls and other compliance related tasks e.g. non-conformances.
  • Participates in the review of current and future CSV procedures and polices
  • Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Participates in regulatory audits and communicates company's computer validation policies.
  • Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps.
  • Manages projects and prepares status reports using Microsoft project and other communication tools.


Education and Experience:

  • Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure
  • Qualification/validation; will substitute relevant experience for education.
  • Experience in a GMP environment essential.
  • Biologics experience highly desirable

Apply via this advert or contact Paul O'Driscoll at (021) 477 7329 if you have any more questions about this opportunity!

Please note to apply for this contracting opportunity you must hold an EU passport or have a Stamp 4 work permit. We regret that we are unable to provide visa or work permit sponsorship at this time.

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
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