CSV Engineer

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

Key responsibilities for this role include:

• Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) projects.
• Support and co-ordinate the qualification and validation processes
• Support activities include, but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
• Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures. This individual will provide compliance leadership, direction and execution in Computer System Validation for new projects.
• Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams.
• Responsible for ensuring that the Technical Services Manager is consulted on all validation deliverables.
• Conduct validation training with project team communicating deliverables, procedures and methods.

The minimum qualifications for this role are:

• Looking for A minimum of a Bachelor’s degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech)
• Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
• Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
• Strong knowledge of computerized system development life cycle approach is required.
• The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
• Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.
• Excellent PC skills with proficiency in automation systems.
• Experience of coordination of Quality documentation and in particular, qualification/Validation documentation.
• Strong written and verbal communication skills are required