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 ® 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
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