CSV Engineer - Validation & Compliance Specialist

EFOR; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

EFOR in Ireland seeks a highly skilled CSV validation specialist to lead validation activities for complex Information System projects within a highly regulated pharmaceutical environment, ensuring compliance from design through deployment.

You will coordinate qualification efforts, develop comprehensive plans and documentation (IQ/OQ/PQ, URS, risk assessments, traceability matrices), oversee data migration, SOPs and change controls, and provide guidance on GMP requirements.

Qualifications

• Minimum a Bachelor's degree with at least 3 years' CSV industry experience (Pharma/Biotech).
• Experience validating ERP, MES, LIMS and Quality Systems.
• Thorough knowledge of cGMP regulations (21 CFR Part 11, EU Annex 11) required.
• Strong ability to work independently and adapt to changing priorities.
• Proven leadership and cross-functional teamwork abilities.

Responsibilities

• Manage and execute validation deliverables for new IS projects.
• Coordinate qualification and validation processes.
• Prepare validation plans, risk assessments, URS, traceability, IQ/OQ/PQ, data migration, SOPs, changes.
• Ensure systems meet regulatory requirements and company policies.
• Provide leadership on CSV for new projects.
• Train project teams on validation procedures and deliverables.

Skills

CSV experience

Regulatory compliance

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in life sciences/related field

Tools

ERP

MES

LIMS

Job description

EFOR in Ireland seeks a highly skilled CSV validation specialist to lead validation activities for complex Information System projects within a highly regulated pharmaceutical environment, ensuring compliance from design through deployment.

You will coordinate qualification efforts, develop comprehensive plans and documentation (IQ/OQ/PQ, URS, risk assessments, traceability matrices), oversee data migration, SOPs and change controls, and provide guidance on GMP requirements.