Résumé
Au cours de la phase de démarrage de l’opération, le Technicien de production sera responsable de l’exécution des protocoles de qualification et commissioning des équipements USP (Upstream Processing) ou DSP (Downstream Processing) et zones de production associées. Pendant les opérations de production, le Technicien de production assumera un rôle opérationnel en pilotant les outils de ligne de production et en relevant déviations.Les équipements USP incluent les incubateurs, les flux laminaires, les bioréacteurs é usage unique (rockers, STR).Les equipements DSP incluent les mixeurs desoluitions, les skids de chromatographie, de filtration, d’UFDF, etc.
Rôle et Responsabilités
Pendant la phase de construction, vous allez principalement:
- Effectuer et supporter les SAT, IQ, mise en service, OQ et PQ.
- Supporter les contrôles de modification, y compris les actions correctives éventuelles
- Participer activement à la rédaction des recettes
- Contribuer à la mise en place de la zone de production (room layout)
Pendant la phase opérationnelle, vous allez principalement:
- Créer, revoir, toutes les procédures standard, fiches de travail, protocoles PQ et autres documents qualité
- Agir en tant qu’exemple pour les autres membres de l'équipe pour assurer la production en temps voulu des lots et proposer de manière proactive la résolution des problèmes
- Reporter, enquêter et fermer les déviations et non-conformités
- Exécuter des activités liées à la libération de lots
- Participer aux efforts d’amélioration continue
- Contribuer positivement à une forte culture d'intégrité et d'éthique dans les affaires Agir dans le respect des exigences légales et de conformité ainsi que des directives de l'entreprise
- Délégation à : Spécialiste production Manufacturing
Votre profil
- Diplôme en pharmacie ou biotechnologie industrielle ou toute expérience équivalente en industrie chimique, agroalimentaire pharmaceutique ou biotechnologie
- Travail de shift
- Capacité à travailler dans un environnement rapide et hautement réglementé
- Esprit d'équipe
- Une expérience de terrain prouvée en production cGMP est un plus
- Français, l’anglais est un plus
Job Summary (Primary function)
During the facility startup phase, the Production Operator / Technician will be responsible for executing commissioning and qualification protocols of manufacturing equipment and areas. This may include medium preparation, inoculum, bioreactors (rockers, STR), depth filtration, and cell clarification equipment, chromatography, UFDF, etc
During manufacturing operation, the Manufacturing Production Opertaor / Technician will develop in an operations based role.
Essential Functions of the Job (Key responsibilities)
During the construction phase, you will mainly:
• Perform FAT, SAT, IQ, Commissioning and OQ. Up to 25% European travel required
• Support Change Controls and deviations including any corrective actions arising during verifications
• Execute and review test reports
• Perform and report PQ activities
• Prepare and deliver training to new members of the team
During operational phase, you will mainly:
• Draft, review all required Standard Operating Procedures, Work Instructions, Manufacturing Batch Records, PQ protocols and other quality documents related to areas of responsibility, as well as support other areas as required
• Act as an example in the cleanroom to ensure timely batch execution, and proactively propose problem resolution
• Raise, investigate and close events, deviations and non-conformances
• Execute batch related activities
• Actively participate in continuous improvement initiatives - proposing and implementing with team
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Biotechnology or pharmaceutical degree preferred or relevant experience from chemical, food, pharmaceutical or biotech industry
• Shift work is expected
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
• Ability to work in a fast paced – high regulated environment
• Team work oriented mindset
• A first hands-on experience is a bonus
• French, English is a bonus
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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