Technician Bulk Operations

Le Technician Bulk Operations

The Technician Bulk Operations will be responsible for ensuring the manufacturing activities of products (capsules or tablets), in compliance with BPF/cGMP regulations, hygiene rules, and safety. They must adhere to the procedures defined by the pharmaceutical site's quality system.

Responsibilities

• Perform production operations such as weighing materials, preparing powder mixtures, and operating automated lines in capsule or tablet activities according to their training curriculum and following the procedures in force of the quality system.
• Technically support operators in production activities.
• Master the ERP tool (MES) in the management of batch records and associated consumptions.
• Master and perform cleaning of equipment and related rooms for different production stages.
• Perform format changes and production line emptying.
• Update and create technical documents necessary for the operation of equipment and line (usage instructions, cleaning).
• Comply with directives and instructions defined in the quality system of our pharmaceutical site.
• Ensure the production of industrial batches in a GMP environment and work autonomously and efficiently according to the instructions of their supervisor.
• Control, record, and complete pre-established work documents to ensure a follow-up of the operations performed (GMP filled batch records).
• Perform elementary physical controls of manufactured products.
• Participate and support the validation of industrial processes and the manufacture of validation batches.
• Comply with the production objectives, particularly respecting the established schedule.
• Generate maintenance intervention requests in case of equipment breakdowns and follow up until production resumes.
• Analyze equipment breakdowns and support maintenance in case of intervention.
• Open deviations in the quality information system.
• Perform format changes and basic adjustments defined in the procedures.
• Be the technical reference for operators.
• Train new employees and operators on different production lines and be the reference for the training (On the Job Qualified Trainer).
• Comply with the safety and security rules of the pharmaceutical site.
• Announce dangerous situations, near misses/accidents, and accidents that could occur on the site to their direct supervisor and to the EHS department.

Qualifications

Experience / Education

• Have an initial training level of CFC and 5 years of experience in pharmaceutical production or ideally 3 years as a technician in the pharmaceutical industry.

Knowledge / Skills / Abilities:

• Perfectly know the BPF/GMP environment, and have good knowledge of the pharmaceutical industry, particularly in the sector of powder mixing and encapsulation and/or compression.
• Have perfect mastery of French and notions of English (A2).
• Be organized and rigorous, and have great relational qualities for teamwork.
• Communicate clearly with support services.
• Have a critical mind and be a force of proposal for continuous improvement.
• Have knowledge of computer tools (Word, Excel) and MES.
• Share knowledge and train new employees, operators on the different equipment of the bulk area.