Beschreibung
PLC Automation EngineerExciting opportunity to join our biopharmaceutical client, which 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.