Beschreibung
PLC Automation EngineerExciting opportunity to join our biopharmaceutical client, who is rapidly growing to start production of its first commercial product. They are currently searching for a dynamic and motivated automation engineer to support preparations for an upcoming FDA audit.
Job Description:
Supporting the client with preparations for their first FDA audit. This audit will be to give them the go ahead to start production on their first every product.
The systems they use are all based on PLC/HMI/SCADA - Siemens.
The work will include hands on projects, documentation review and preparation, driving compliance to FDA requirements and closing compliance gaps.
The process/equipment involved are upstream fermentation, downstream purification (no fill/finish).
Educational/Experience Requirements
Experience as an Automation Engineer in a (Bio)Pharmaceutical or Medical Device environment.
Previous experience of CapEx or compliance improvement projects desired.
Strong knowledge of GAMP5 and requirements of 21 CFR Part 11.
Experience with PLC/HMI/SCADA systems required, preferably Siemens.
Communicate effectively with diverse stakeholders from QA, Manufacturing, QC and Engineering departments to drive project goals and deliverables.
German language skills beneficial, but not essential.