Computer Systems Validation Engineer
Our client based in Waterford requires a permanent Computer Systems Validation Engineer
to join their team in the Global Centre of Excellence for QC Laboratory Instruments. Reporting to the Associate Director of Global IT, the successful candidate will be responsible for validation, the qualification and implementation of data integrity standards for laboratory software.
• Writing, building and maintaining a library of validation packages for Laboratory Equipment for use by all laboratories.
• Planning, executing and documenting the full validation lifecycle for the first time qualification of new computerised laboratory equipment in a cGMP regulated environment.
• Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirements.
• Ensure system compliance with Data Integrity standards and assist with remediation if required.
• Provide 2nd Level Support to QC on Instrument Issues.
• Train laboratory personnel on new software applications as part of first time qualification projects.
• The ideal candidate will be a qualified pharmaceutical professional with several 3-5 years experience in validation, compliance and quality.
• BSc. in Chemistry or Computer Science.
• Project Management experience preferred.
• Excellent knowledge of USP, cGMPs, and cGLPs.
• Excellent knowledge of QC laboratory practices in a pharmaceutical Quality Control environment.
• Excellent computer skills including MS Office, Windows.
• Strong communication skills both verbally and written and excellent interpersonal skills.
• Ability to work independently or in a team environment through cooperative participation in department and interdepartmental teams.
• Ability to travel is a requirement of this role and flexibility with regard to working hours.
Clodagh Nerney | Tel: +353 (0) 1 507 9254