Technician Downstream Manufacturing

This position will be a 5-month mission via an agency.

Job summary

Responsible for technical activities for GMP Manufacturing Operations in a multi-products biopharmaceutical facility.

This position includes supporting safety, compliance, quality, scheduling, production record generation and revision, production process execution, equipment onboarding, process improvement projects ownership and manufacturing training.

The individual will also assist to tech transfer and new project integration activities for manufacturing, record generation, equipment enrollment, operation, and maintenance, and conduct operational excellence initiatives for the department.

The DSP Manufacturing Specialist will report to the Associate director of DSP department.

The individual will be responsible for managing the day-to-day, and mid-term schedule planning and be the primary point of contact for daily issue escalation.

The individual will ensure strict accordance with SOPs and Good Manufacturing Practices. The individual will also be responsible for overwatching cross-functional operations are both reliable and successful. This requires a drive for continuous improvement and simplicity and looking for opportunities to ensure equipment operation is reliable.

Job Responsibilities
- Oversee manufacturing activities including: manufacturing record generation, MRP BOM and work order generation, and enrollment of materials and equipment
- Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed
- Ensure staff maintain a high level of compliance to procedures and quality expectations.
- Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed
- Ensure equipment and manufacturing facilities remain in working order by overseeing manufacturing specialists and ensuring that vendor repairs who will production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.

Minimum Requirements
- Bachelor’s degree in a related scientific or engineering discipline and 4+ years’ experience in related GMP manufacturing operations
- Demonstrated knowledge of purification unit operation is required. Experience in single-use platform technology is preferred.
- Good written and verbal communication skills are required
- Energetic, motivated and dynamic individual.
- Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
- Fluent in French Language both reading and writing. Communication abilities in English is preferred.
- Ability to speak effectively before groups of customers or employees of organization.
- Computer Skills :MS Office, ERP, EDMS, production equipment software, other
- Equipment Use: Peristaltic Pumps, chromatography skids and Other Single Use pumps, Balances, pH and Osmolality meters, Other lab equipment, other production equipment, and Office Equipment

Working conditions
- Open to work on on-call activities /Shifts 2x8
- 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._