IT CSV Specialist
Job ID: JOB-13131
The IT Lab Computer System Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations.
We are seeking an enthusiastic and experienced IT Lab CSV Engineer to join our team on a long-term contract basis. The IT Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments.
The position will work within a collaborative Computerised Instruments team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
- Minimum 3 years’ experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
- Experience of analyzing and challenging s/w to identify gaps.
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
- 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, both within and outside of the laboratory area
Role will involve:
- Manage lab equipment validation projects from software install to business release
- Prioritize CSV activities in line with the project schedule and monitor budgets
- Generate computer system validation documentation, e.g. Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
- Review of software release notes
- Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
- Determine any specific configurations for the software, e.g. how data is saved and named
- Understand and define user permissions
- Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
- 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
- Produce documentation that is well written and consistent throughout the document body e.g. headings, font type, font size, paragraph spacing, text alignment, correct tense
- Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
For further information on this role in CSV please contact Michael Brennan on Hire@hero.ie or 086-440 3742
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
Apply Now Job ID: JOB-13245 R&D Manager – Photochromic and Liquid Crystal Technology Company Overview: Over 25 years of successful…
Apply Now Job ID: JOB-13243 Senior Quality Compliance Specialist Purpose This role participates in maintaining site compliance of operations inclusive…
Apply Now Job ID: JOB-13235 Manufaturing Engineering Supervisor Location: Clare Great opportunity to to be part of a diagnostics manufacturing…