OPENING! Product Engineer, Downstream Processing

My client is a biotech company that is currently expanding worldwide, and and they are currently building a new team on the site. It is a highlghy visible role with lots of impact as, in this site, you will be responsible for developing processes which will be transferred and implemented at other sites as well.

You will be an active part of the newly established Drug Product, Downstream Technology and Automation group of a state-of-the-art biotechnology facility and significantly contribute to the design, qualification, and validation of a new integrated manufacturing process from vial thaw to secondary packaging. You can work on cross functional assignments as well to gain broad experience.

Responsibilities include but are not limited to:

• Define new business processes around Drug Product Manufacturing to support the startup of the new group.
• SOPs, Batch Documents, Inventory, Spare Parts, Manufacturing Capacity Planning
• Design Visual Inspection Qualification Program for the manual inspection program
• Design, Qualification, Validation and Maintenance of equipment that supports Drug Product manufacturing and new Technology within Downstream Processing.
• Work with other colleagues from around the network; coordinating activities, evaluating best practices in other areas, and working on continuous improvement project.
• Support the development of Batch Documentation for DP Manufacturing.
• Execute Batch Document / Run Equipment on the Process floor in coordination with other members of the team (Setup, Filling, Visual Inspection).
• Provide support for Process Simulations (Microbial / Personnel) and Investigations.
• Support coordination of daily work schedules and effectively organize needed support groups by attending the Tier meetings.
• Investigate and Purchase New technologies to bring efficiencies to the organization and make the area a leader of innovation within the global network

Qualification:

• University degree (MSc/BSc) in Biology, Pharmacy, Process engineering, or another relevant discipline
• Familiarity with Biotech Manufacturing processes and a general understanding of Downstream Unit Operations
• Competent in analyzing complex situations and show practical problem solving capabilities
• Effective verbal or spoken communication skills
• Good communication skills in German and English
• Preferred Experience and Skills:
• At least 3 years of work experience in the pharmaceutical or biotech industry (sterile manufacturing of pharmaceutical or biological components/finished products)
• Demonstrated Microbiological knowledge and practical experience

Call me, Arnaud Schmitt-Fillaire, at NonStop Recruitment now for a confidential conversation at +41 43 508 08 17 and please send your CV (ideally in MS Word format) at: a.schmitt-fillaire@nonstop-pharma.ch

OR if this does not sound like the opportunity for you, but you are a professional within the Pharmaceutical industry, please feel free to get in touch, to see other opportunities we may have within this field.

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