USP Senior Technician
vor 2 Wochen
Within the Drug Substance Development (DSD) - Manufacturing department, we are looking for a USP Senior Technician who will support the USP large-scale operations (GMP and pilot).
You will be part of a team of technicians, engineers, and scientists specialized in the production and purification of recombinant proteins produced from animal cells.
You will support the USP activities from an operational and documentation point of view: cell expansion, bioreactor process in fed-batch / perfusion.
You will support the activities related to the transfer of USP operations to the new site currently under construction. You will address various topics such as equipment, process, and automation issues.
You will be responsible for:
- Performing operational USP activities
- Facilitating tech transfer and scaling-up
- Analyzing data, presenting it, and interacting with different entities: QC, QA, or project managers.
- Carrying out documentation related to your function, writing protocols, reports, and procedures.
- Participating in maintaining the functionality of the laboratories / clean rooms.
- Participating in the continuous improvement of the area and its activities by proposing and implementing improvement projects.
- Participating in test activities during the qualification of process equipment in the context of corrective or improvement changes if necessary.
Minimum Requirements:
- You have a technician diploma (CFC, HES, BTS, IUT...) with 2-3 years' experience in USP.
- You speak French and English (written and reading comprehension a plus).
- Knowledge of USP processes is a must.
- Knowledge of BPF, GLP, and/or GMP.
- Knowledge of IT tools (Pack Office, Trackwise / SAP, DeltaV, MES, LIMS) is a plus.
- You are able to work as part of a team and have good communication skills with all stakeholders (Managers, Unit managers, scientists, and technicians) and stakeholders from other departments (Production, QC, QA...).
- Ideally, experience in the field of pharmaceutical production (USP development, clinical, and commercial).
- Training in Operational Excellence (LEAN, BELT) is a plus.
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