Industry Pharma/Biotech/Clinical Research City Cork Province Cork Country Ireland Job Description Why Simo Tech What is it like towork at Simo Tech? With a strong collaborative teamwork culturebased on respect, trust, and excellence, we play a criticalpartnering role in our clients' life-changing supply of productsto patients.
In return, there is an excellent salary, benefits,career progression, educational support and much more.
Simo Tech has an opportunity for a Computer Systems Validation Engineerto join our team, supporting our client at a state-of-the-art biotechnology site in Cork.
The successful candidate will have2+ years' experiencein a similar role within the life sciences industry, and will support automation projects with a focus on validation activities.
This role involves validation support for automation systems, and requires strong skills in non-conformance investigation and technical writing.
Key Responsibilities Assistin creating and executing validation strategies for new and existing automationcomputerisedsystems.
Support the implementation and validation of Delta V DCSand related automation systems.
Write and review key validation documents, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Validation Plans.
Carry out risk assessments on validation activities.
Identifyand resolve validation test deviations or failures.
Support the creation of traceability matrices and change controls for validated systems.
Preparing validation summary reports.
Provide support during audits and inspections from a validation perspective.
Ensure work is completed in compliance with industry standards and regulations, including 21 CFR Part 11, GAMP5, and EU Annex 11.
Collaborate with the Quality Assurance team toidentifyand amend any compliance gaps and to improve validationprocesses.
Requirements Key Requirements Bachelor's Degree in Engineering, Information Systems, Computer Science or Life Sciences.
Minimum of 2 years' experience as a CSV Engineer, supporting Delta V automation in a pharmaceutical environment.
Familiarity with 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity guidelines.
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 Simo Tech Can Offer Roleprovides a high degree of autonomy to allow the successfulcandidate to reach their full potential.
Simo Techcan facilitate these positions as a staff engineer or contract engineer.
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