GMP Compliance Expert

1 week ago


Cork, Cork, Ireland Fastnet Full time

We are looking for a highly experienced Senior Process Engineer to join our team at Fastnet.

The successful candidate will have a strong background in process engineering, with a degree in a relevant field, such as Process, Chemical, Mechanical or equivalent discipline.

They will also have experience in leading engineering initiatives in a GMP/GCP compliant environment, with a minimum of 5-8 years of experience.

Biopharma operations experience and 3+ years of directly related experience in Filling Operations are essential for this role.

The ideal candidate will be responsible for ensuring that process engineering activities are implemented in a compliant manner.

This includes provision of technical engineering support to Drug Product Filling operations, including process performance monitoring, troubleshooting, and process optimisation.

You will also be responsible for fulfilling system ownership responsibilities for assigned Drug Product Filling equipment, including production recipe and cleaning recipe updates where required.


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