CSV Quality Engineer - GxP Systems Validation Specialist

Pinewood Healthcare; Ballymacarbry; On-site; EUR 55,000 - 75,000; Full time

Job summary

Pinewood Healthcare, a leading provider of healthcare products, is seeking a Quality Engineer - CSV to support validation of GxP computerised systems across our sites in Ireland. You will partner with QA, IT, Manufacturing and external suppliers to ensure systems are validated and compliant throughout their lifecycle.

The ideal candidate has at least 2 years' CSV experience, a relevant engineering or IT degree, and practical knowledge of GAMP 5 and EU GMP Annex 11.

Qualifications

• Minimum 2 years' CSV experience in a regulated pharma/biotech/medical device environment.
• Experience preparing and executing CSV documentation (IQ, OQ, PQ).
• Bachelor's degree in a relevant engineering or IT field.
• Ability to apply risk-based validation and comply with EU GMP Annex 11 and GAMP 5.

Responsibilities

• Support the validation and lifecycle management of GxP computerised systems.
• Prepare, review and execute Computer System Validation documentation.
• Develop and maintain validation documents including GxP Assessments, URS, IQ, OQ, PQ and Validation Plans.
• Execute validation testing and document results.
• Perform risk assessments using a risk‑based approach in accordance with GAMP 5.
• Support change controls, deviations, investigations and CAPAs related to computerised systems.
• Review supplier documentation and support supplier qualification activities.
• Support audit trail reviews, user access reviews and backup verification activities.
• Ensure compliance with EU GMP Annex 11, GAMP 5, Data Integrity principles and internal QMS requirements.
• Work closely with QA, Manufacturing, Engineering, IT and external suppliers on validation activities.

Skills

CSV principles

Technical writing

Cross-functional collaboration

Software systems understanding

GAMP 5 knowledge

Data Integrity (ALCOA+)

Education

BSc in CS/Engineering

CSV training

Job description

Pinewood Healthcare, a leading provider of healthcare products, is seeking a Quality Engineer - CSV to support validation of GxP computerised systems across our sites in Ireland. You will partner with QA, IT, Manufacturing and external suppliers to ensure systems are validated and compliant throughout their lifecycle.

The ideal candidate has at least 2 years' CSV experience, a relevant engineering or IT degree, and practical knowledge of GAMP 5 and EU GMP Annex 11.