Industry Pharma/Biotech/Clinical Research
City Cork
Country Ireland
Job Description
Why SimoTech
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.
We have a new opportunity for a SeniorAutomation Engineer to join the SimoTech team, supporting one of our clients, aglobal leader in the medical technology field.
This senior position will be part of thesite Automation team and will hold responsibility for the design, development,and oversight of automation systems across the facility.
The ideal candidate will act as a seniortechnical authority on automation design, integration, reliability, andcompliance, ensuring all automation solutions meet regulatory expectationsincluding GAMP and 21 CFR Part 11.
This role is suited to an experiencedautomation professional with proven leadership experience within Life Sciencesmanufacturing environments.
This is a fully onsite role.
Key Responsibilities
Providesenior-level ownership of complex automation control system issues, ensuringtimely resolution and long-term reliability.
Lead the design and review of automation systemsfor new equipment, upgrades, and facility modifications.
Manage medium-to-large automation projects fromconcept through design, planning, execution, validation, and handover.
Support day-to-day operation of site automatedsystems, occasionally outside normal working hours, including troubleshooting,corrective/preventative actions, and system optimisation.
Create, maintain, and approve automationspecifications, standards, and procedures to ensure systems remain compliantwith regulatory and industry requirements.
Represent Automation on site initiatives,continuous improvement programs, and cross-functional engineering projects.
Maintain automation-related inventories, backups,and system/user administration processes.
Lead and approve changes to qualitydocumentation—such as investigations, deviations, and change controls—relatedto automation systems.
Work proactively with operations and engineeringteams to support investigations, issue resolution, and timely closure of NCsand CAPAs.
Stay current with emerging automation technologiesand contribute to long-term automation strategy.
Requirements
Qualifications &Experience
Bachelor'sDegree in Engineering, Computer Science, or similar.
Minimum of 7 years'experience as an Automation Engineer within pharmaceutical, biotech or otherhighly regulated Life Sciences manufacturing environments.
Strong hands-onexperience with PLC control systems, ideally including Siemens SIMATIC(S5–S******) and Rockwell ControlLogix platforms.
Proficient in DCS/SCADAsystems such as WinCC, WinCC Flexible, and FactoryTalk View Studio.
Solid understanding ofindustrial communication protocols such as ProfiNET, ProfiBUS, ASiBus, Modbus,and OPC UA/DA.
Understanding ofhigher-level systemse.g.
historian.
EBRand OT networks.
Demonstrated experienceexecuting engineering projects and supporting automation system lifecycleactivities.
Strong knowledge ofGAMP, GxP, and 21 CFR Part 11 compliance requirements.
Excellent verbal andwritten communication skills, with proven ability to work acrossmulti-disciplinary teams.
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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