CSV Engineer

SimoTech; Leinster; In loco; EUR 90.000 - 110.000; Tempo pieno

Descrizione del lavoro

SimoTech is seeking a CSV Engineer to join our biopharmaceutical client project in Co. Dublin. The role is fully onsite and requires a minimum of 6 years’ experience in GMP and validation disciplines, with deep knowledge of regulatory requirements (21 CFR Part 11, Eudralex Annex 11, GAMP 5).

You will author C&Q plans, URS, FAT, IOQ, and related documentation. Candidates should have a strong background in QA/QC interfaces, cross-functional collaboration, and a track record of delivering compliant

Competenze

• Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
• Minimum 6 years’ experience in GMP and validation disciplines.

Mansioni

• Authoring and managing C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation.
• Monitor FAT and IOQ execution activities and ensure alignment with test scripts.

Formazione

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

Strumenti

Kneat

MES

PI Data Historian

PCS

Lab systems

Descrizione del lavoro

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.

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.
• 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.

Key Requirements

• 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 on exciting capital projects.