CSV Engineer

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

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

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

The successful candidate will have a minimum of 6 years’ experience in developing and validating automation documentation and working closely with SMEs, vendors, & quality teams to ensure compliance with regulations, timelines and operational needs.

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.
• Develop and maintain templates for all SDLC deliverables in compliance with client standards, ensuring consistent implementation of validation strategies. Deliverables include, but are not limited to, Requirements Specifications, Requirements Traceability Matrices (RTM), Functional Specifications, Data Integrity Assessments, Design Specifications, Code Reviews, and Test Specifications/Test Scripts.
• Conduct system walkdowns and verification of technical documentation and drawings, including P&IDs, as-built drawings, and related engineering documentation, to ensure accuracy and compliance.
• 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.

Qualifications & Experience

• 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, and their alignment with EU and US FDA regulatory requirements.
• 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 to be authored with support from other SMEs.
• Experience working with one or more of the following systems: MES, PI Data Historian, PCS, Lab systems, 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 and the ability to work effectively across cross-functional teams.

What SimoTech Can Offer

• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
• Develop new skills and enhance technical ability by working with innovative technologies in a multi- disciplined environment.
• Opportunity to work with large corporate clients