Job Description

Arcadis DPS Engineering are seeking a QA CSV Engineer for a pharmaceutical assignment located in Cruiserath, Co. Dublin. This is a 12-month contract position. 

Key Responsibilities

• Develop/execute IQ, OQ, PQ for computer systems & software
• Collaborate cross-functionally (IT, QA, Operations)
• Perform risk assessments, impact analyses
• Create/maintain validation documentation (plans, test scripts, traceability matrices, reports)
• Conduct periodic compliance reviews
• Change control participation
• Project team guidance on CSV principles
• Stay current with regulatory and CSV trends
• Vendor/supplier compliance for 3rd-party systems
• Support regulatory inspections/audits
• Qualification of lab instruments and automation systems (DeltaV, MES, etc.)

Requirements

• Bachelor’s degree in computer science, Engineering, or related field
• Strong regulatory knowledge (FDA 21 CFR Part 11, EU Annex 11, GAMP 5)
• CSV experience in regulated industry (pharma/biotech preferred)
• Experience with risk-based validation methodologies
• Ability to create/execute protocols and document activities
• Strong analytical/problem-solving and attention to detail
• Communication & interpersonal skills for cross-functional work
• Ability to work independently, manage multiple projects
• Knowledge of SDLC and change control
• Understanding of data integrity

Why Join Arcadis?

At Arcadis, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, you’ll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy.

Our Commitment to Equality, Diversity, and Inclusion

We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreams—Age, Disability, Faith, Gender, LGBT+, and Race— we foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.