Work Schedule
Other
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
Job Description
Under the direction of the Department Supervisor and/or Team Lead, the incumbent performs the tasks and activities listed below, for which they have been qualified through the required training, in compliance with company and departmental Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and applicable Health & Safety regulations.
Prepare filling lines within the Sterile Area at the start of manufacturing activities and monitor the proper product feed throughout the filling process. Perform integrity testing of 0.22 μm sterilizing filters (hydrophilic and hydrophobic), including both in-housing and disposable filters, according to the frequencies specified in current SOPs and the instructions provided in the Batch Records. Perform dissolution and filtration of pharmaceutical products in accordance with the instructions specified in the Batch Records. Accurately complete Batch Records and maintain departmental documentation related to assigned activities. Perform raw material identification using the designated computerized systems. Perform cleaning, washing, and sterilization of reactors and tanks within the Injectable Manufacturing Department, in accordance with current SOPs and the weekly production schedule. Ensure the proper storage and preparation of materials required for connecting reactors and tanks, following current SOPs and meeting the timelines established by the weekly production schedule. Prepare disinfectant solutions for the routine cleaning of the Sterile and Pre-Sterile Areas in accordance with current SOPs. In coordination with Production Supervisors, transfer materials required for manufacturing activities into the production area using autoclaves and pass-through systems, according to the production schedule. Ensure the proper storage and preparation of materials required for connecting reactors and tanks, following current SOPs and meeting the timelines established by the weekly production schedule. Perform routine operational checks to verify the proper functioning of equipment and machinery in the preparation area, in accordance with current SOPs. Perform routine testing and sterilization of hydrophobic filters installed on lyophilizers, following the procedures described in current SOPs. Ensure proper care and handling of equipment, materials, and the work environment, promptly reporting any abnormalities or malfunctions to the Supervisor. Clean the work area upon completion of manufacturing activities in compliance with current SOPs. Perform chemical and microbiological sampling activities and complete the associated documentation in accordance with current SOPs.
Education
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High school diploma with a scientific focus, or middle school diploma with relevant proven work experience.
Training
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Successful completion of all required training and qualification programs applicable to the role.
Knowledge, Skills & Experience
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Basic knowledge of pharmaceutical manufacturing processes in a GMP-regulated environment.
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Ability to follow Standard Operating Procedures (SOPs), Batch Records, and production instructions accurately.
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Familiarity with aseptic manufacturing principles and sterile production environments is preferred.
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Good attention to detail and strong documentation practices.
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Ability to work effectively as part of a team.
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Basic computer skills for the use of production and inventory management systems.
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Commitment to quality, safety, and compliance with cGMP requirements.
