Description
Our biopharmaceutical manufacturing client has undertaken a large expansion of its manufacturing facilities to allow for its first commercial production runs. The equipment and process engineering team is currently looking for a CSV engineer to support them with a number of automation projects. You will initially be involved with a fermenter upgrade and will move on to support with additional new and upgrade equipment projects.Location: Düsseldorf Region, Germany
Duration: 6 months initial contract
Responsibilities:
• Fermenter Control System upgrade project:
o Create a validation plan for the fermenter upgrade project.
o Review FAT documentation from the vendor.
o Attend the FAT and write relevant reports.
o Review IQ/OQ/PQ reports.
o Work closely with the vendor through the implementation and coordinate CSV activities.
o Resolve any deviations.
• Support ongoing new and upgrade biotech equipment projects.
• The successful candidate will also be tasked with supporting the development of a CSV strategy for the site.
Requirements:
• Extensive previous experience working as a CSV Engineer within the Pharmaceutical/ Bio-pharmaceutical industry, with a thorough knowledge of GAMP5 requirements.
• Thorough knowledge of the requirements of 21 CFR Part 11.
• Experience of supporting FAT from client side including attendance, documentation review and writing of reports.
• Experience with PLC and SCADA systems required.
• Communicate effectively with diverse stakeholders from QA, Manufacturing, QC and Engineering departments to drive project goals and deliverables.
• Personal attributes include self-motivation, excellent communication skills, strong team player and proactive attitude to problem solving.
• German language skills beneficial.