Validation Compliance Engineer

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