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 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 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.
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.
- Familiarity with validation methodologies, including risk-based validation approaches.
Apply via this advert or contact Paul O'Driscoll on 021 4777 329 if you have any more questions about this opportunity!
