Hybrid DeltaV CSV Engineer for Pharma Validation

SimoTech; Cork; Hybrid; EUR 65,000 - 95,000; Full time

Benefits offered by this job

Autonomy

Educational support

Career progression

Job summary

SimoTech in Ireland invites a DeltaV CSV Engineer to join our biotech manufacturing client in Limerick. You will validate computerised systems within process automation, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP5.

The role offers hybrid working, exposure to state-of-the-art facilities, and opportunities to develop skills in risk assessments, IQ/OQ/PQ, and validation documentation across URS/FRS.

Qualifications

• Bachelor’s degree in engineering, information systems, computer science, or life sciences.
• Minimum of 5 years’ experience as a CSV Engineer in a pharmaceutical environment.
• Experience validating DeltaV and Siemens PLC automated systems.
• Knowledge of 21 CFR Part 11 and EU Annex 11.

Responsibilities

• Create and execute validation strategies for new or existing validated systems.
• Assist with implementation and validation of DeltaV, Siemens PLC, and related systems.
• Write and review validation documents (URS, FRS, IQ, OQ, PQ) and validation plans.
• Perform risk assessments on validation activities and manage deviations.
• Create traceability matrices and manage change controls.

Skills

Cross-functional collaboration

Attention to detail

Technical writing

Problem solving

Education

Bachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences

Tools

DeltaV

Siemens PLC

URS/FRS IQ/OQ/PQ

GAMP5

Job description

SimoTech in Ireland invites a DeltaV CSV Engineer to join our biotech manufacturing client in Limerick. You will validate computerised systems within process automation, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP5.

The role offers hybrid working, exposure to state-of-the-art facilities, and opportunities to develop skills in risk assessments, IQ/OQ/PQ, and validation documentation across URS/FRS.