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 on 021 4777329 if you have any more questions about this role!
