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!
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.
- Knowledge of Validation principles and processes
- Basic understanding of the regulatory requirements associated with data integrity and validation including: ALCOA+, 21CFR Pt 11 and EU Annex 11.
Apply via this advert or contact Paul O'Driscoll on 021 4777 329 if you have any more questions about this opportunity!
