SimoTech require a CSV Engineer for a Pharmaceutical site based in Cork. The selected candidate will be responsible for the Computer System Validation of lab automation and IT solutions being implemented across the site. The CSV Engineer will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
KEY RESPONSIBILITIES
- Manage the computer system validation aspect of lab automation and IT projects from software install to business release.
- Generate computer system validation documentation in accordance with site procedures and regulatory requirements including 21 CFR Part 11, Annex 11 and GAMP5.
- Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria.
- Perform data integrity risk assessments.
- Identify, resolve and test data integrity related issues.
- Work with the business to identify and implement procedural controls to mitigate issues found during testing.
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
- Determine solutions or recommendations for changes and/or improvements.
- Prioritize validation activities in line with the project schedule.
- Collaborating with global IT and Quality teams.
- Minimum 5 years’ CSV experience.
- Experience of writing validation plans, test protocols and reports.
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines.
- Strong Data Integrity experience.
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
- Self-motivated, detail-oriented and excellent organizational and time management skills.
- Capable of relating well to other people with whom s/he comes in contact.
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
