Work Schedule
OtherEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowedJob Description
In accordance with the instructions received from the Department Manager and/or Department Lead, the employee performs the tasks and activities listed below, for which they have been qualified through the appropriate training, in compliance with company and departmental SOPs as well as applicable safety regulations.
Prepare the filling lines within the Sterile Area at the start of production activities and subsequently monitor the correct product feeding process.
Perform integrity testing of 0.22-micron sterilizing filters, both hydrophilic and hydrophobic, including housing and disposable types, according to the frequencies specified in the current SOPs and the instructions reported in the Batch Records.
Carry out the dissolution and filtration of pharmaceutical products according to the instructions provided in the Batch Records.
Complete Batch Records and archive departmental documentation related to the activities performed.
Perform raw material identification using computerized information systems.
Conduct the cleaning and sterilization of reactors and tanks within the Injectable Products Department, following the instructions described in the current SOPs and in accordance with the weekly production schedule.
Ensure the proper storage and preparation of materials required for connecting the various reactors and tanks, following current SOPs and meeting the timelines established in the weekly production plan.
Prepare disinfectants for the routine cleaning of Sterile and Pre-Sterile Areas, as described in the current SOPs.
In coordination with Supervisors, manage the transfer of materials required for production activities based on the products to be manufactured, using autoclaves and pass-through systems.
Ensure the proper storage and preparation of materials required for connecting the various reactors and tanks, following current SOPs and adhering to the timelines established in the weekly production schedule.
Perform periodic checks to verify the correct operation of machinery and equipment in the preparation area, as required by current SOPs.
Carry out periodic testing and sterilization of hydrophobic filters installed on lyophilizers, following the instructions described in the current SOPs.
Take care of machinery, materials, and the work environment, promptly reporting any anomalies or issues to the supervisor.
Clean the work environment at the end of production activities in compliance with current SOPs.
Perform chemical and microbiological sampling activities and complete the related documentation in accordance with current SOPs.
Based on 4,465 disclosed Operations salaries on RoleSuite, the role pays a median of $110K/year, with most offers between $83K and $145K (10th–90th percentile: $66K–$184K).
See the full Operations salary breakdown →