DeltaV CSV Engineer

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

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 require an DeltaV CSV Engineer to join our team, supporting a biotech manufacturing facility for our multinational biopharma client based in Limerick. You will join a state-of-the-art facility, incorporating new technologies, with a specific focus on operational flexibility, environmental sustainability, and fast track delivery concepts.

The successful candidate will support the validation of computerised systems within the process automation framework, ensuring their compliance with pharmaceutical industry standards and regulations. The ideal candidate will have extensive experience as a DeltaV CSV Engineer in a pharmaceutical environment. The role offers a hybrid working model.

Key Responsibilities

• Create and execute validation strategies for any new or existing process automation computerised systems.
• Assist with the implementation and validation of systems including DeltaV, Siemens PLC, Pi etc.
• Write and review validation documents including User Requirement Specifications (URS), Functional Requirements Specifications (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Validation Plans.
• Carry out risk assessments on validation activities.
• Identify and resolve validation test deviations or failures.
• Creation of traceability matrices.
• Change controls and impact assessments for validated systems.
• Create and execute test cases for the verification of system functionality and data integrity.
• Preparation of validation summary reports.
• Provide support for audits and inspections from a validation perspective.
• Ensure all work is completed in compliance with industry standards and regulations including 21 CFR Part 11, GAMP5, and EU Annex 11.
• Provide validation and industry standards & regulations training to relevant team members.
• Work in conjunction with the Quality Assurance team to identify and amend any compliance gaps and to improve validation processes.

Qualifications & Experience

• 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 supporting process automation systems and manufacturing technologies from a CSV perspective.
• Good knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.
• Hands on experience validating DeltaV and Siemens PLC automated systems.
• Working knowledge of risk management practices and tools such as FMEA.
• Strong written and verbal communication skills with the ability to work in a cross-functional team.
• Strong attention to detail, organisational and problem-solving skills

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