Back to job search View more
New
Validation Compliance Engineer
Cork Contract Competitive
About the job
Morgan McKinley is partnering with a leading multinational who is seeking a Validation Compliance Engineer to join a new product launch team. This is a 12 month hourly rate contract position.
The Role;
- Support Validation Compliance Team to comply with all the requirements of USFDA 21 CFR and EudraLex Vol. 4 GMP chapters on CSV/Validations and Annex 11requirements.
- To review the Audit trails of all equipment (lab, facilities and ops) at site.
- To review periodic performance qualifications (ERP and all equipment across the site).
- To perform validation assessments for new equipment/instruments and change of design for validated equipment.
- To review DI gap assessments in lab/manufacturing and support remediation plans.
- To review validation documents (IQ/OQ/PQ)and summary reports for validation exercises
- Trouble shooting for risk assessments (mitigations), deviation investigations and CAPA's.
Required;
- Degree in Engineering or a Scientific related discipline.
- 3 - 5+ years of experience in a life sciences environment (must be GMP regulated).
- Strong communication and organizational skills.
If you are keen to further develop your career working with a highly collaborative team please reach out today to hear more about this exciting opportunity. For more information please contact Orla Casey 021 230 0497
