Manufacturing Support Technician

vor 3 Wochen

PlanlesOuates, Schweiz KBI Biopharma Vollzeit

This position is a temporary position and contract will be established by an external agency for KBI Biopharma. The duration will be 5/6 months.

Immediate availability is required for this position.

Job summary

The Manufacturing Support Technician position is responsible for Raw Material weighing, Dispensing, Buffer and Media preparation, Process Assemblies (PA) generation, and all logistics within the Manufacturing common Area.

This position performs all routine/non-routine cleanings of the GMP common areas, manage Process Waste, and continuously supports the manufacturing operations. This position requires a shift schedule. Aseptic and Gowning Qualifications are required for this position.

Must be able to document and maintain records to comply with regulatory requirements, cGMP’s, Policy Documents and SOPs.

Job Responsibilities
- Perform Dispensing, Buffer and/or Media preparation manufacturing activities operations and related IPC’s
- Schedule and Perform Raw Materials Dispensing/Sampling - Requires more in-depth knowledge on Aseptic practices.
- Schedule, order materials, prepare, build and complete processing assemblies (PARs) for production.
- Clean, operate and maintain the Process Waste area. Ensure cleanliness of the area and discards waste materials within the area. Maintain Manufacturing common facilities by routine/non-routine cleanings. (Daily, Weekly and Monthly Cleanings) and Perform the required response cleanings.
- Communicate status updates with other affected departments.
- Author, revise and initiate Standard Operating Procedures, PARs, Deviations.
- Prepare, communicates and reviews the completions of daily shift assignments and logbook reviews.
- Ensures accuracy of inventory.
- Ensure CAPA closures.
- Train and perform autoclave operations.

Job Requirements
- High School Diploma with 1.5 years’ experience./ Bachelor Degree.
- Certified Trainer for cleaning, PARs, material movement and Autoclave, and Aseptic and Gowning Qualifications.
- Ability to deal with problems involving several concrete variables in standardized situations.
- Ability to stand, walk, wear steel toe shoes and have the ability to push, pull, squat, lift, reach and carry waste as needed
- Ability to operate internal computer systems, and management of Microsoft Word, Microsoft Excel, E-mail
- Fluent in French is necessary to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Basic English understanding (reading) is desired.

Working Conditions
- Due to non-routine cleanings and the manufacturing schedule, it is required to stay past the assigned shift to complete such cleanings.
- Due to the use of Spor-Klenz, respirators (full faced and half faced respirators) are required for the job description. Additionally, facial hair needs to be maintained short enough to ensure a good seal to properly wear the respirator.
- 2x8 Shifts adaptability are required on this position.
- 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._

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