LSC have a great contract opportunity for a Lab 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.Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements.If you have 3 years previous industrial experience in a similar role and are ready for your next challenge, this could be the perfect project for you ABOUT THE PROJECT
- KEY RESPONSIBILITIES: The CSV Engineer (Computer System Validation Engineer) is responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices.Responsibilities: Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for laboratory analytical instruments (e.g Cell Viability Analysers etc.) Create and execute test protocols designed to verify compliance of the system with data integrity principles and regulatory requirements.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.ABOUT YOU
- ARE YOUR SKILLS A MATCH? Bachelor's degree in Engineering, Science, Computer Science or a related field.Experience working in a similarly large biologics company, preferably within a Validation, Analytical or Quality Assurance role.
xsokbrcKnowledge of Validation principles and processes Basic understanding of the regulatory requirements associated with data integrity and validation including: ALCOA+, 21 CFR Pt 11 and EU Annex 11.