Overview
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. 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!
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).
Create and execute test protocols designed to verify data integrity and regulatory compliance of the system.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure regulatory and internal policy compliance.
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
Bachelor's degree in Engineering, Science, Computer Science or a related field.
Experience in a similarly large biologics company, preferably within a Validation, Analytical, or Quality Assurance role.
Knowledge of validation principles and processes.
Basic understanding of regulatory requirements related to data integrity and validation, including ALCOA+, 21 CFR Part 11, and EU Annex 11.
Apply via this advert or contact Paul O'Driscoll at 021 4777 329 if you have any more questions about this opportunity.
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