JOB SUMMARY:

Our client is seeking a highly experienced Lab IT Systems Specialist to join our team in Athlone. This role is ideal for a professional with deep expertise in computer systems validation, laboratory systems integration, and compliance with GxP and data integrity standards. The successful candidate will ensure the robust and compliant operation of lab IT systems and support digitalization initiatives within QC laboratories.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s Degree or higher in Computer & Software Engineering, Electronic Systems, or a related field.
• Minimum 10 years’ experience in Computer System Validation (CSV) and Software Quality in pharmaceutical or medical device environments.
• Proven experience validating laboratory systems such as OSI PI, Rockwell Plantpax, Werum PAS-X, and SAP interfaces.
• Strong knowledge of GxP regulatory requirements and industry standards for computerized systems.
• ASQ Certified Six Sigma Green Belt preferred.
• Excellent communication and project management skills.
  Job Types: Full-time, Fixed term

Benefits:

• On-site parking

Schedule:

• Monday to Friday

Education:

• Bachelor’s (required)

Experience:

• IT Lab: 5 years (required)
• Pharmaceutical: 5 years (required)

Work Location: In person
Reference ID: 31286

• Act as a Subject Matter Expert (SME) for laboratory IT systems, including data historians, electronic batch records, and lab instrument interfaces.
• Perform validation and revalidation of laboratory computerized systems in compliance with GAMP 5, 21 CFR Part 11, and Annex 11.
• Author and review system documentation including URS, FS, risk assessments, IQ, OQ, PQ, RTM, and validation reports.
• Collaborate with cross-functional teams (QC, QA, IT, Engineering) to manage system implementation and upgrades.
• Provide oversight on data integrity and computer system lifecycle management for laboratory equipment.
• Participate in and support audits and inspections, acting as the validation SME for lab systems.
• Lead continuous improvement initiatives within the lab IT landscape, focusing on compliance, automation, and efficiency.