DeltaV CSV Engineer 1685

Simotechnology; Limerick; On-site; EUR 70,000 - 90,000; Full time

Job summary

SimoTech in Limerick is seeking a DeltaV CSV Engineer to support a biotech manufacturing facility for a multinational biopharma client. You will validate computerised systems within the process automation framework to ensure compliance with industry standards.

The ideal candidate has 5+ years’ CSV experience in pharma, hands-on DeltaV and Siemens PLC validation, and strong cross‑functional communication. This role offers a hybrid work model, ongoing training, and exposure to advanced

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.
• Hands-on experience validating DeltaV and Siemens PLC systems.
• Knowledge of 21 CFR Part 11, EU Annex 11 and GAMP5.
• Experience with risk management tools like FMEA.
• Strong written and verbal communication and cross-functional collaboration.

Responsibilities

• Create and execute validation strategies for new or existing process automation systems.
• Assist with validation of DeltaV, Siemens PLC, and other systems.
• Write and review URS, FRS, IQ, OQ, PQ, and Validation Plans.
• Carry out risk assessments and address deviations.
• Create traceability matrices and manage change controls.
• Prepare validation summary reports and support audits/inspections.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP5.
• Collaborate with Quality Assurance to close compliance gaps.

Skills

DeltaV

Process automation

Risk management

Cross-functional teamwork

Communication

Attention to detail

Education

Bachelor’s degree in Engineering/Information Systems/Computer Science/Life Sciences

Tools

Siemens PLC

FMEA

Job description

Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients’ life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.

SimoTech require an DeltaV CSV Engineer to joinour team, supporting a biotech manufacturing facility for our multinationalbiopharma 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 thevalidation of computerised systems within the process automation framework,ensuring their compliance with pharmaceutical industry standards andregulations. The ideal candidate will have extensive experience as a DeltaV CSVEngineer in a pharmaceutical environment. The role offers a hybrid workingmodel.

Key Responsibilities

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

Requirements

Qualifications &Experience

• Bachelor’sDegree in Engineering, Information Systems, Computer Science or Life Sciences.
  
• Minimumof 5 years’ experience as a CSV Engineer in a pharmaceutical environment.
  
• Experiencesupporting process automation systems and manufacturing technologies from a CSVperspective.
  
• Goodknowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.
  
• Handson experience validating DeltaV and Siemens PLC automated systems.
  
• Working knowledge of risk management practicesand tools such as FMEA.
  
• Strongwritten and verbal communication skills with the ability to work in across-functional team.
  
• Strongattention to detail, organisational and problem-solving skills
  

What SimoTech CanOffer

• Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
  
• Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
  
• Opportunity towork with large corporate clients