Validation Compliance Engineer

Cork
Contract
Full-time

27 days ago

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

Morgan McKinley

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