Computer Systems Validation - Consultant- Hybrid

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 is the world’s number one professional services firm and making an impact is more than what we do. It is why we are here. We bring challenge, curiosity and edge to every project, driving positive progress for our clients, our people, our communities and the planet. This purpose inspires us to work to the highest standards and to tackle the challenges that matter. Number one never stops challenging. Audit and Assurance is one of Deloitte Ireland’s largest service lines and a core engine of our business. As the world’s number one professional services firm, we bring challenge, curiosity and edge to the financial reporting ecosystem. We deliver insight, confidence and value for leading local and international clients. Our teams combine advanced technology with deep professional expertise to evolve our audit and assurance processes. You will work with talented colleagues across our global network to make an impact that matters every day. Number one never stops challenging and neither do we. We offer a competitive starting salary of €45,000.00 for this role, with salary adjustments reflecting your experience level and expertise.

Why you’ll enjoy this new opportunity Deloitte is the world’s number one professional services firm and making an impact is more than what we do. It is why we are here. We bring challenge, curiosity and edge to every project, driving positive progress for our clients, our people, our communities and the planet. This purpose inspires us to work to the highest standards and to tackle the challenges that matter. Number one never stops challenging. Audit and Assurance is one of Deloitte Ireland’s largest service lines and a core engine of our business. As the world’s number one professional services firm, we bring challenge, curiosity and edge to the Life Sciences sector. We deliver insight, confidence and value for local and international clients. You will work with talented colleagues across our global network to make an impact that matters every day. Number one never stops challenging and neither do we.

Key skills and prior experience that align well with this position

• 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 Food and Drug Administration (FDA) or European Medicines Agency (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

What type of work will I be doing?

• Prepare and execute, and review validation deliverables for computerised systems in compliance with FDA, EMA, ICH, and other relevant regulations
• Advising clients in CSV best practice and regulatory compliance
• Completing validation activities to client requirements
• Supporting client in risk based approach and identify process improvement opportunities
• Providing CSV guidance and support to project teams in the resolution of validation documentation corrections and/or test defects
• Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit requirements and industry best practices
• Manage validation change control documentation and support CAPA and quality metrics programmes
• Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5 and data integrity expectations
• Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and responses

Who is the Hiring Manager?

The hiring manager is a Senior Manager in the Audit and Assurance team in Deloitte and specialises in Computerized System Validation (CSV). They supports the delivery of validation solutions for clients in the Life Sciences and Healthcare industries and has extensive experience in CSV with expertise in Agile Methodologies and in the core cGMP requirements related to CSV, required to deliver CSV in the highly regulated life sciences industry. They are experienced in advising clients in CSV best practice and leading CSV project engagements with the client including delivering policies, procedures and conducting validation activities to client requirements.

Where is this role based?

This role is based in our Cork or Limerick offices with a flexible hybrid working model that supports a blend of office and remote working. Client site visits may be required depending on project needs. For more information, please visit our Deloitte Works webpage.

What we offer

Your reward at Deloitte is competitive, purpose driven and designed to support your growth. It is more than salary. We invest in your personal and professional development, empower your work life balance and offer benefits that support you at every stage of life.

• health and wellbeing supports
• pension and savings options
• training and coaching
• enhanced leave options

Deloitte is the number one professional services firm in the world, and the leading global provider of audit and assurance, consulting, financial advisory, risk advisory, sustainability, tax, and related services. We have offices across Ireland in Dublin, Belfast, Cork, Limerick and Galway. Deloitte is proud of the enhanced flexibility that we offer our people through our hybrid working strategy, Deloitte Works. It means we trust our people with the flexibility and control to make the right choices in where, when, and how they work. Deloitte is looking for people that have a leadership mindset, are curious, enjoy solving challenges and are eager to grow their careers.

Deloitte is an equal opportunities employer and will ensure that any reasonable accommodations are implemented throughout the recruitment and selection process.