CSV Validation Engineer for Biopharma Systems

Grifols; Dublin; On-site; EUR 75,000 - 110,000; Full time

Benefits offered by this job

Private Medical Insurance

Pension Plan

Annual Bonus

Share Options

Education allowance

Wellness events

Job summary

Grifols is seeking an experienced CSV Validation Engineer to join our Validation team in Ireland. You will act as SME for Computer System Validation across major capital projects, validating software, automated equipment, manufacturing systems and cloud platforms to ensure GMP compliance and data integrity.

You will collaborate with Quality, Operations, IT, Engineering and Maintenance, participating in audits and maintaining the Validation Master Plan.

Qualifications

• 3+ years in CSV/CSA, Validation or Quality in biopharma.
• Strong CSV/CSA expertise and GxP systems qualification.
• Experience validating MES, LIMS, SaaS/cloud platforms.
• Knowledge of FDA/EMA regulations and data integrity.
• Excellent documentation and audit support.

Responsibilities

• Write, review and execute validation protocols and reports.
• Review change controls and define validation requirements.
• Represent validation at audits by HPRA and FDA.
• Develop CSV project documents and SOPs.
• Support validation activities including FAT, IQ, OQ, PQ, UAT.
• Maintain Site Validation Master Plan and coordinate re-validations.
• Conduct risk assessments and close CAPAs.
• Lead qualification across cross-functional teams.

Skills

CSV Validation

Regulatory Compliance

Data Integrity

Documentation

Project Management

Audits

GxP Knowledge

Cross-functional Collaboration

Quality Assurance

Biopharma IT

Education

Science/Engineering degree

Tools

MES

LIMS

SaaS/Cloud platforms

SCADA

BMS

DCS

QMS

Job description

Grifols is seeking an experienced CSV Validation Engineer to join our Validation team in Ireland. You will act as SME for Computer System Validation across major capital projects, validating software, automated equipment, manufacturing systems and cloud platforms to ensure GMP compliance and data integrity.

You will collaborate with Quality, Operations, IT, Engineering and Maintenance, participating in audits and maintaining the Validation Master Plan.