Computer Systems Validation - Senior Consultant

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.

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Why you’ll enjoy this opportunity?

The Validation Engineer role is pivotal in ensuring manufacturing equipment, processes, and computerised systems meet the highest compliance standards, including cGMP and regulatory requirements. You will have the opportunity to lead validation projects that directly impact product quality and operational excellence, collaborating with diverse teams and driving continuous improvement in a dynamic, regulated environment.

What type of work will I be doing?

• Preparing, executing, and reviewing validation deliverables for manufacturing equipment, processes, and computerised systems.
• Assessing validation requirements for new equipment, change controls, and revalidation activities.
• Advising on CSV best practices and regulatory compliance.
• Supporting risk-based validation approaches and identifying process improvements.
• Collaborating with cross-functional teams including manufacturing, quality assurance, IT, and project management.
• Participating in risk assessments, design reviews, and validation lifecycle activities.
• Supporting internal and external audits and managing validation change control documentation.
• Driving continuous improvement initiatives to enhance validation processes and compliance.

What skills, qualifications and experience do I need?

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, IT, or a related discipline.
• Proven experience in validation engineering or quality assurance within a cGMP-regulated or similarly regulated environment.
• Proven expertise in process validation and/or computerised systems validation (CSV experience preferred).
• Strong understanding of regulatory frameworks including FDA, EMA, ICH, and data integrity principles.
• Excellent organisational, project management, and communication skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Willingness to travel to customer sites and perform site-based validation duties.

Who is the hiring manager?

The hiring manager is an experienced leader within Deloitte’s Life Sciences and Manufacturing team, known for fostering a collaborative and supportive environment. They value clear communication, professional development, and innovation, encouraging their team to deliver excellence in compliance and operational effectiveness while maintaining a strong client focus.

Where is the role based?

This role is based in Limerick, Cork or Dublin with a hybrid working model that includes office, client sites, and hybrid work. Occasional travel to customer sites is expected.

For more details, please visit our Deloitte Works webpage.

If you meet most of the criteria above, we encourage you to apply. Deloitte is an equal opportunities employer and will ensure that any reasonable accommodations are implemented throughout the recruitment and selection process.

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. These include health and wellbeing supports, pension and savings options, training and coaching and enhanced leave options.