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.