CSV Engineer 1598

4 weeks ago

Dublin, Ireland Simotechnology Full time

Dun Laoghaire, Ireland | Posted on 14/10/2025

- Industry Pharma/Biotech/Clinical Research
- Province Dublin
- Country Ireland

Why SimoTech

What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust,and excellence, we play a critical partnering role to ourclients’ life-changing supply of products to patients . In return, there is excellent salary, benefits,career progression, educational support andmuchmore.

SimoTech has a new opportunity for a CSV Engineer to join our team, supporting the validation for aDrug Product Facility project for our biopharmaceutical client based in Co. Dublin.The successful candidate will have a minimum of 3 years’ experience in developing and validatingautomation documentation and working closely with SMEs, vendors, & quality teams to ensurecompliance with regulations, timelines and operational needs. This is a fully onsite role.

Key Responsibilities

- Responsible for authoring and managing the C&Q plan, PCS automation validation plans, URS,FAT, IOQ documentation and summary reports, in collaboration with cross-functional teams.
- Monitor FAT and IOQ execution activities, ensuring alignment with test script intent, identifying &resolving protocol issues and executing CSV related tests on lines and equipment.
- Ensure all automation deliverables comply with regulations and industry best practice standards.
- Maintain consistency and traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ,STQM/RTM and summary reports.
- Identify risks and recommend improvements to the C&Q and automation qualification strategy,documentation quality, and test execution.
- Share key learnings to facilitate effective knowledge transfer for future projects.

Requirements

Qualifications & Experience

- Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
- Minimum 3 years’ experience in GMP and validation disciplines, with a strong understanding ofpharmaceutical design, build, commissioning, & validation processes, and their alignment with EUand US FDA regulatory requirements.
- Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
- Experience working with one or more of the following systems: MES, PI Data Historian, PCS, Labsystems, QBMS, or inspection line control systems.
- Experience working with paperless validation systems (Kneat) would be an advantage.
- Demonstrate excellent interpersonal and communication skills, with strong attention to detail andthe ability to work effectively across cross-functional teams.

What SimoTech Can Offer

- Role provides a high degree of autonomyto allow the successful candidate to reach their fullpotential.
- Develop new skills and enhance technicalability by working with innovative technologies in amulti- disciplined environment.
- Opportunity to work with large corporateclients

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