MS&T USP Engineer - 9 months mission

☞ KBI Biopharma

View: 178

Update day: 04-04-2024

Location: Plan-les-Ouates Genève GE

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Biotechnology Research

Position: Entry level

Job type: Full-time

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Job content

This position is a temporary mission of 9-month duration.

Job Summary

The MS&T USP Process Engineer will apply sound scientific and engineering principles to successfully contribute to the transfer and enrolment of new biopharmaceutical processes into the cGMP manufacturing facility.

The scope of this role includes:
  • Support technical transfer projects for complex, off-platform and later stages clinical programs
  • Actively contribute to business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client
  • Perform facility fit evaluations including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, and generation of planning & overage bill of materials (BOM) and new material specifications
  • Provide on the floor technical support for cGMP production runs, deviations, change controls and CAPAs
  • Compile process data and communicate out to the client and upper management via production updates and campaign summary reports
  • Support complex investigational and troubleshooting efforts and provided recommendations to manufacturing for implementation
  • Contribute to collaboration on strategic projects or studies with external partners (i.e., process development, vendors) and present results in technical reports or wider industry publications

Job requirements
  • BS in Science or Engineering with minimum of 8 years industry experience, Masters with 5 years industry experience or PhD with 2 years industry experience
  • Must have demonstrated biologics expertise in upstream processing and operations
  • Good understanding of technical transfer and scale up is highly desired
  • Experience with GMP compliance requirements is desired
  • Sound knowledge of Process Development and cGMP production operations
  • Experience working in a cGMP manufacturing environment is a plus
  • Proficiency in French and English (oral & written) and overall communication is required

KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
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Deadline: 19-05-2024

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