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Process Engineer (f/m/d) 100%

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Offered by:

Bacthera AG

Medical
Visp

Act as Process Expert within the Bacthera organization. Contribution to successful implementation of process and corresponding documentation. Manages operational activities of assigned manufacturing projects. Is accountable for the performance and results of assigned projects.

Role and Responsibilities

  • Support and execution of facility and process setup activities for SER-109 process to ensure successful transfer into the manufacturing plants according to overall project timelines
  • Setup and maintenance of GMP process transfer documentation and risk assessments. Deliver process k-how, scientific expertise as well as operational excellence into LBP-production and continuous improvement
  • Performs manufacturing activities according to cGMP guidelines.Responsible to establish timely and with high quality the required production documentation (e.g. Batch Record Review, Deviation Reports, Risk Assessments, Changes)
  • Executes trouble shooting, deviation- and change-management. Anticipate, respond and permanently resolve issues that arise during production. Will consult and work with SMEs from other departments
  • Supports Operations Drug Substance (DS) / Drug Product (DP) in training and planning tasks
  • Contributes to the development and implementation of standardized Manufacturing procedures and processes
  • Driving continuous improvements in performing and ensuring alignment to current industry guidance and practices
  • Represents Manufacturing during regulatory inspections and customer audits as SME
  • Responsible to follow SHE standards and rules
  • Works closely with MSAT department and Quality organization. Ensures a good information exchange and issue escalation throughout all organizational levels and functions
  • On call duty
  • Live and contribute to the Bacthera culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside the own area of responsibility
  • Implements a vision as service provider and customer focus in the organization

 Your Profile:

  • Bachelor-/Master degree with Biotechnology, Biochemistry or related disciplines as the preferred area of study
  • Experience of 3 to 8 years in a related field within Bioproduction
  • Strong leadership skills; very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; high motivation and dynamic drive; solution-oriented
  • Excellent biotechnology expertise and/or kledge in biotechnical engineering preferable in the area of protein purification and/or drug product activities
  • Fluent in German/English; advanced GMP understanding

 You will be based in Visp, Switzerland and will report to the Head of DS /DP. Some travel, or defined training period at another site, can occur (e.g., to other Bacthera locations).Are you interested to work for an innovative, dynamic, and future oriented start-up company? And if you are looking for a new challenging role, where you can create things and contribute to the set-up of the organization? If yes then send your full application to Ms. Sandra Gamboni, Global Head of Human Resources; [email protected]