LSC have a great contract opportunity for a CSV Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
About the Project – Key Responsibilities
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
About You – Are Your Skills a Match?
Bachelor's degree in Computer Science, Engineering, or a related field.
Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Paul O Driscoll if you have any more questions about this role!
Skills: IQ OQ PQ CSV
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