Industry Pharma/Biotech/Clinical Research
City Cork
Country Ireland
Job Description
Why SimoTech
What is itlike to work at SimoTech?
With a strong collaborative teamworkculture based on respect, trust, and excellence, we play acritical partnering role in our clients' life-changingsupply of products to patients.
In return, there isexcellent salary, benefits, career progression, educationalsupport and much more.
SimoTechrequire a CSV Engineer to join our team, supporting one of our large-scalepharmaceutical manufacturing clients, based in Co.
Cork.
The ideal candidate will have at least 3 years'experience working in a Life Sciences manufacturing environment working onsystem validation activities, including protocol development, execution, andcompliance with regulatory standards.
This is a hybrid setup, ideally 3 days onsiteper week.
Key Responsibilities
Reviewof project lifecycle CSV deliverables, including the review and approval ofProject Verification Plan, and Configuration Management Plan (CMP).
Pre-approvaland post-approval of Software Test Specifications (STS) and Hardware TestSpecifications (HTS)
Reviewand approval of Exceptions raised during testing.
Reviewand close-out of project change controls.
Reviewand approval of Requirements Traceability Matrices (RTM) and Automation TestSummary Reports (ATSM).
Generation and review of Computer System periodicreview reports.
Review of Computer System User Access review reports.
Maintenance of Compliance Schedule for periodicand access review reports.
Generation of QTS actions to capture reportdeliverable requirements.
Creation and update of remediation plans forERES assessments.
Generation and CSV review of automation-specificSite Operating Procedures (SOPs).
Maintenance of the automation SOPs, forms, andcontrolled documents list.
Liaison with Training Automation Administratorto manage training requirements.
Generation and review of Electronic Records andSignatures (ERES) assessments.
Periodic review of Quality Risk Management (QRM),including the frequency of Periodic Review Process, User Access Review Process,and the review and approval of other Data Integrity (DI) assessments.
Requirements
Qualifications& Experience
Bachelor's Degree in IT, Information Systems,Computer Science or Engineering.
Minimum3 years' experience as a CSV Engineer in the Life Sciences industry.
Knowledgeof the different phases of automation projects in GXP/GMP environments.
Knowledgeof DCS/PLC/SCADA/HMI control systems.
Knowledgeof GMAP5 and Batch S88 standards.
Excellentcommunication and presentation skills.
What SimoTech Can Offer
Roleprovides a high degree of autonomy to allow thesuccessful candidate to reach their fullpotential.
SimoTechcan facilitate these positions as a staff engineer orcontract engineer.
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