Randstad Professionals is looking for a Chemical Engineer for External Manufacturing for a major client based in Lucerne.
Contract period: 12 months
Start date: 01.01.2021
The clients Large Molecule External Manufacturing Technology team requires a Technical Specialist to join their high performance team in Europe. The successful candidate will assist the site tech ops leads in their responsibilities for the management of the technical interface between the company and the external partners supporting the Bulk Vaccines and Biologics Drug substance for commercial and clinical manufacturing operations. Reporting the External Manufacturing Vaccines Drug Substance Technology lead, the successful applicant will demonstrate high levels of drive, enthusiasm, flexibility and innovation to support the diverse portfolio.
Reports to External Manufacturing Vaccines Drug Substance Technology lead, and receives general direction on goals and objectives.
Works closely with assigned site tech ops lead for day to day responsibilities.
Supports facility start-up and technical transfer to an EP for new products and/or provide global technical operations support for continuous commercial manufacturing at an external partner for existing products
Collaborates with Large Molecule External Manufacturing Operations, External Quality Operations and others on the Integrated product team (IPT) to support the product lifecycle
Supports validation strategies for new and existing products.
Support internal and external changes to ensure compliant manufacture of products
Performs reviews of external partner documents including but not limited to, change controls, batch records, validation studies and technical communications.
Troubleshoot manufacturing issues and support investigations through scientific problem solving approaches
Understands regulatory requirements and partners with Operations, Quality, and the external Partners to develop more efficient ways to meet these requirements.
Partners with EP's to achieve business goals and to establish a common culture that benefits both.
Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
If you are interested to take on these responsibilities you should have the following requirements:
Qualified candidates must have a minimum Bachelor degree in chemical/biochemical engineering, pharmaceutical science or chemistry/biology or related disciplines
Minimum of six months of experience supporting the areas of bulk biologics manufacturing, technical transfer OR have demonstrated experience in these areas of process validation, scale up or process engineering
Must be able to multi-task and work within tight deadlines.
This position requires flexibility and the ability to work independently, as well as excellent organizational skills.
Strong professional and interpersonal communication skills are also required.
Preferred but not required to have previous experience in External Manufacturing, Change Control Management, Deviation management, Validation and Statistical analysis
Travel up to 30% primarily in EU
We can offer you a new challenge in a diverse, innovative and multicultural environment. Have we sparked your interest? Then we look forward to receiving your online application.
Please note a Swiss Work permit or EU-citizenship is mandatory for this position.
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