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Senior Associate @ Russell Tobin || MBA in Human Resources || Recruitment
Are you an experienced CSV Engineer looking to take on your next contract role in a cutting-edge biopharma environment? We’re hiring a Computer System Validation Engineer to support large-scale projects involving manufacturing automation systems, analytical lab instruments, and enterprise systems.
What You’ll Do:
Develop and execute validation protocols (IQ/OQ/PQ) for computer systems and software
Collaborate with IT, QA, and Operations to ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5
Conduct risk assessments and impact analyses
Create and maintain validation documentation (test scripts, traceability matrices, summary reports)
Perform periodic reviews and support audits/inspections
Participate in change control processes and ensure proper validation
Support qualification of manufacturing systems (DeltaV, MES) and lab instruments (e.g., Cell Viability Analyzers, Liquid Handlers)
Work with vendors to ensure 3rd party system compliance
Use tools like ValGenesis, Kneat, or HP ALM for paperless validation
What We’re Looking For:
Bachelor’s in Computer Science, Engineering, or a related discipline
5+ years’ experience in CSV within pharma or biotech
Strong knowledge of FDA 21 CFR Part 11, Annex 11, and data integrity principles
Experienced in SCADA/PLC controlled systems (e.g. filling lines, isolators, lyophilizers)
Hands-on experience with Emerson DeltaV
Proficiency in risk-based validation, SDLC, and change control processes
Ability to multitask and manage projects independently
Strong documentation and communication skills
This is a long-term contract opportunity to work with leading-edge technologies and cross-functional teams in one of Ireland’s most innovative biopharma environments. You'll have real impact on the validation of systems critical to delivering safe, life-changing medicines.
Apply now or share with your network!
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Information Technology, Manufacturing, and Quality Assurance
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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