USP Technician - 9 months mission

Job content

Job Summary

The Upstream Manufacturing Technician will be responsible for upstream unit operations such as seed expansion, bioreactor operations, cell culture harvest activities.

The Upstream Manufacturing Technician will have a working knowledge of upstream processing equipment : incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment.

Additionally, the Upstream Manufacturing Technician will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers).

Job Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations
• Execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures
• Document each task involving manufacturing records and logbooks following GDP at the time of execution
• Review the executed production records and logbooks to ensure GxP compliance
• Ensure all materials are issued and accounted for during the execution of a record (i.e. SR, EPR and BR)
• Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities
• Participate and be accountable for room 5S
• Utilize and perform maintenance on equipment per applicable SOP
• Work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment
• Work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant
  
  

Job Requirements

• Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations; or high school diploma with 4-6 years’ experience in related GMP manufacturing operations
• Working knowledge of Upstream operations is preferred
• Experience in single-use platform technology is preferred
• Excellent written and verbal communication skills are required
• Energetic, motivated and dynamic individual
• Organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Fluent in French
• English level capabilities can be an asset
  
  

Working conditions

The job requires working on shifts which may include working overnight as well as week-end or “on duty” working periods.

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.