Life Sciences CSV Consultant - Regulatory Validation Expert

Deloitte Ireland LLP; Cork; Hybrid; EUR 45,000 - 60,000; Full time

Benefits offered by this job

Health & wellbeing supports

Pension & savings options

Training & coaching

Enhanced leave options

Job summary

Deloitte Ireland LLP seeks a Senior CSV Specialist to validate computerised systems in life sciences, ensuring compliance with FDA/EMA and GAMP 5. The role blends office and client-site work in Cork or Limerick, with a flexible hybrid model.

You will advise clients on CSV best practices, lead validation deliverables, and support CAPA and quality metrics programmes while collaborating with cross-functional teams.

Qualifications

• Software, IT, Pharma, Science degree or related discipline.
• Proven experience in IT related field; experience in systems such as JIRA, Trackwise, Veeva Vault
• A flair for technology and computing
• Experience of validating computerised systems with AI integration is preferable but not essential
• Experience in working in regulated industries preferable; solid understanding of EudraLex Volume 4, including Annex 11, FDA 21 CFR 11 and Good Automation practices (GAMP)
• Understanding of SDLC and methodologies such as Agile and Waterfall
• Basic understanding of quality management systems and data integrity principles
• Experience managing CAPA lifecycle activities, supporting inspection readiness for FDA or EMA audits
• Experience applying 21 CFR Part 11, European Union Annex 11, GAMP 5, and data integrity requirements, including ALCOA+ principles
• Proficiency with MS Office Tools

Responsibilities

• Prepare, execute, and review validation deliverables for computerised systems per FDA/EMA/ICH regulations
• Advise clients in CSV best practice and regulatory compliance
• Complete validation activities to client requirements
• Support client in risk-based approach and identify process improvement opportunities
• Provide CSV guidance to project teams and resolve validation documentation and test defects
• Monitor systems and processes to ensure SOPs and audit readiness
• Manage validation change control documentation and support CAPA and quality metrics programmes
• Apply risk-based validation to assess system impact and compliance with GAMP 5 and data integrity
• Drive inspection readiness activities, including gap assessments and mock audits

Skills

Software, IT, Pharma, Science degree

IT validation experience

Regulated industries knowledge

SDLC and Agile/Waterfall

CAPA & FDA/EMA audits

18 CFR/21 CFR familiarity

MS Office proficiency

Tools

JIRA

Trackwise

Veeva Vault

MS Office Tools

Job description

Deloitte Ireland LLP seeks a Senior CSV Specialist to validate computerised systems in life sciences, ensuring compliance with FDA/EMA and GAMP 5. The role blends office and client-site work in Cork or Limerick, with a flexible hybrid model.

You will advise clients on CSV best practices, lead validation deliverables, and support CAPA and quality metrics programmes while collaborating with cross-functional teams.