Senior CSV Validation & Automation Engineer (Onsite)

SimoTech; Dublin; On-site; EUR 80,000 - 110,000; Full time

Job summary

SimoTech has a new opportunity for a CSV Engineer to join our team, supporting validation for a Drug Product Facility project for a biopharmaceutical client based in Co. Dublin.

The role is fully onsite and requires a minimum of 6 years’ experience in developing and validating automation documentation, working with SMEs, vendors and quality teams to ensure compliance with regulations. The successful candidate will author and manage C&Q plans, URS, FAT, IOQ, RTMs and related deliverables,

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
• Minimum 6 years’ experience in GMP and validation disciplines, with a strong understanding of pharmaceutical design, build, commissioning, & validation processes.
• Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
• Solid technical understanding of computer systems and PLC automation systems enabling FAT and IOQ protocols.
• Experience with systems such as MES, PI Data Historian, PCS, Lab systems, QBMS, or inspection line control systems.
• Experience with paperless validation systems (Kneat) would be an advantage.

Responsibilities

• Authoring and managing C&Q plans, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports in collaboration with cross-functional teams.
• Monitor FAT and IOQ execution activities, ensure alignment with test scripts, resolve protocol issues and execute CSV-related tests on lines and equipment.
• Ensure all automation deliverables comply with regulations and industry best practices; maintain traceability across C&Q plans and reports.
• Develop and maintain templates for SDLC deliverables in compliance with client standards (Requirements Specifications, RTMs, Functional Specifications, Data Integrity Assessments, etc.).
• Conduct system walkdowns and verification of technical documentation to ensure accuracy and compliance.
• Identify risks and propose improvements to C&Q and automation qualification strategies, documentation quality, and test execution.

Skills

GMP & validation

Regulatory compliance

PLC/automation systems

MES/QA systems

Documentation deliverables

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar

Tools

Kneat

Job description

SimoTech has a new opportunity for a CSV Engineer to join our team, supporting validation for a Drug Product Facility project for a biopharmaceutical client based in Co. Dublin.

The role is fully onsite and requires a minimum of 6 years’ experience in developing and validating automation documentation, working with SMEs, vendors and quality teams to ensure compliance with regulations. The successful candidate will author and manage C&Q plans, URS, FAT, IOQ, RTMs and related deliverables,