Senior CSV Engineer, Biopharma Validation & Automation

SimoTech; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

SimoTech in Ireland is seeking a CSV Engineer to join our biopharma client project in Co. Dublin. You will lead validation documentation, ensure CSV compliance, and collaborate with SMEs, vendors, and quality teams to meet regulatory timelines.

The role requires at least 6 years of GMP and validation experience, familiarity with 21 CFR Part 11, Annex 11, and GAMP 5, and hands-on work with C&Q plans, URS, FAT, IOQ. Strong communication and attention to detail are essential.

Qualifications

• Minimum 6 years' experience in GMP and validation disciplines.
• Knowledge of regulatory requirements including 21 CFR Part 11, Eudralex Annex 11, GAMP 5.
• Strong ability to author and manage validation deliverables and cross-functional collaboration.

Responsibilities

• Author and manage C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and reports with cross-functional teams.
• Monitor FAT and IOQ execution, ensure alignment with test scripts and resolve protocol issues.
• Ensure automation deliverables comply with regulations and best practices.
• Maintain traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, RTM, and reports.
• Develop templates for SDLC deliverables in compliance with client standards.
• Conduct system walkdowns and verification of technical documentation to ensure accuracy.
• Identify risks and suggest improvements to C&Q and validation strategies.
• Share learnings to facilitate knowledge transfer for future projects.

Skills

GMP & validation disciplines

Regulatory compliance knowledge

Cross-functional collaboration

Documentation authoring

Education

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

Tools

MES

PI Data Historian

PCS

Lab systems

QBMS

Inspection line control systems

Job description

SimoTech in Ireland is seeking a CSV Engineer to join our biopharma client project in Co. Dublin. You will lead validation documentation, ensure CSV compliance, and collaborate with SMEs, vendors, and quality teams to meet regulatory timelines.

The role requires at least 6 years of GMP and validation experience, familiarity with 21 CFR Part 11, Annex 11, and GAMP 5, and hands-on work with C&Q plans, URS, FAT, IOQ. Strong communication and attention to detail are essential.