Are you interested in taking the next step in your career with a global leader in the life sciences industry?
Are you ready to challenge yourself in a fast-paced and highly regulated environment?
Are you an experienced IT Compliance & Validation Engineer with a background in GxP?
You could be the perfect candidate for this opportunity!
Don't hesitate, apply today!
Job Description
Our client in Dublin is seeking an experienced IT Compliance & Validation Engineer to join their team and support validation activities for applications, systems and digital solutions.
You will apply IT, quality and regulatory compliance expertise to assess system requirements against validation and assurance activities using risk-based CSA principles.
Key Responsibilities
Ensure compliance with applicable
GxP regulations, corporate quality policies, and divisional procedures
, including data integrity and electronic records requirements
Develop and maintain
risk-based validation and CSA strategies
for medium to large systems
Define validation and assurance approaches for
AI-enabled systems
used in regulated activities (e.g., quality, manufacturing, laboratory, supply chain, clinical, or safety)
Perform and review system impact assessments to determine GxP scope, validation requirements, and CSA testing focus based on patient safety, product quality, and data integrity risk
Develop, review, and approve validation documentation, including
Validation Plans, CSA strategies, risk assessments, test plans, protocols, summary reports, and AI impact assessments
, in accordance with SLC and quality system requirements
Lead the planning, coordination, and execution of validation and assurance activities.
Communicate compliance and validation status through clear, accurate project reporting to stakeholders
Support and review
automated testing and assurance activities
, ensuring testing effort is focused on critical system functionality consistent with CSA principles
Identify, escalate, and resolve compliance issues that may introduce
regulatory, patient safety, product quality, or data integrity risk
Establish validation tasks, milestones, and timelines, and be accountable for delivery.
Capture and report compliance and CSA metrics, identifying opportunities for process improvement and validation efficiency.
Key Requirements
Bachelor's Degree with 5 years of experience in a
regulated life sciences IT or quality systems environment
, or equivalent experience
Demonstrated experience with
GxP computer system validation (CSV)
and
Computer Software Assurance (CSA)
in pharmaceutical, biotech, or medical device environments
Experience supporting or validating
AI-enabled, automated, or data-driven systems
used in GxP processes, with understanding of data integrity, audit trails, security, and lifecycle controls
Strong understanding of global life sciences regulations and guidance (e.g.,
21 CFR Part 11, EU GMP Annex 11, FDA CSA guidance
)
Strong written and verbal communication skills, with proven ability to collaborate with IT, Quality, Regulatory, and business stakeholders in regulated environments.
Benefits
Competitive and attractive employee compensation package
Pension contributions
Health insurance
Paid public holidays
Location
Ireland | remote
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