Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.​

Major Activities of the Job:

Washing & Sterilizing:

• Receive goods I items from the warehouse to be autoclaved for Filling activities.

• Routinely take WFI, Pure Steam, Compressed Air Samplings and deliver to QC labs.

• At the end of the filling batch disassemble, clean, passivate & sonicate units.

• Prepare extensions, filling and stoppering unit for the next scheduled batch.

• Perform TOC and Conductivity Test on Units & Perform EMs in WIS area.

• Prepare Stopper bags for autoclave

• Routinely perform Audit Trail of autoclave records.

• Wash and wrap hard goods in preparation for autoclaving.

• Print labels for all pre-autoclave items and ensure labels are affixed on wrapped units and/or stopper bags prior to autoclaving.

• Ensure there is adequate inventory to perform cleaning & disinfection and to prepare units for filling activities.

• Safely handle acids, detergents, cleaning solutions and WFI as per as our safety guidelines.

• Operate chart recorders (Yokagawa and Chessell Chart recorder).

• Perform Vacuum Leak and Bowie Dick tests at the beginning of each operation day prior to the use of the Fedegari Autoclave.

• Perform filter integrity tests for all filters used during filling activities.

• Perform passivation of filling units.

• Autoclave hard goods, stoppers, and cleaning units using the validated cycle of the autoclave (Fedegari).

• Generate electronic reports for all autoclave cycles in the info tree.

Aseptic Filling Line Set-up​:

• Prepare approved cleaning and disinfection solutions for the cleaning of the Material Transfer Booth (MTB), canisters, and filling machine.

• Prepare all plates aseptically in MTB that will be used during the filling process.

• Select required equipment, parts, and materials needed for the setup in Grade A Restricted Access Barrier System (RABS) and document in the Batch Production Record (BPR).

• Routinely changing RABS gloves as outlined in the respective SOP.

• Assist Mechanic Technician with the removal and installation of vial pockets during batch changeover and verify that the filling parameters in the Filling HMI are consistent with the BPR.

• Confirm the functionality of the in-process check stations (tare and gross) by verifying the test weights and documenting in the BPR.

• Perform prior setup disinfection of the filling machine.

• Setup the filling machine under Grade A Classification.

• Setup the Vial Wash Station and Depyrogenation tunnel under Grade D Classification.

• Perform visual inspection and perform disinfection of the RABS gloves prior to completion of the filling machine setup.

• Aseptically connect the bulk tank to the filling line through use of single actuations aseptic connections.

• Depending on the configuration of the bulk tank, determine the use of recirculation pumps or pressurized nitrogen to start filling.

• Perform required environmental monitoring as outlined in the SOP.

• Perform dose checks ensuring that the fill volume is consistent with the requirements as outlined in the BPR.

• Transfer vial components and load into the Vial Wash station.

• Perform EMs in wash area.

• Load Yokagawa Chart and Chassell Chart recorder in a timely manner prior to starting setup.

Aseptic Filling:

• All operators must gown as per Grade B classification to enter the Aseptic Processing Area.

• All operators operating the vial wash station and the depyrogenation tunnel must be gowned as per Grade D classification.

• During filling, perform routine and non-routine interventions using the RABS gloves as outlined in the Aseptic Process Simulation Study (APSS) ensuring that the Grade A cabinet is not compromised by the Grade B surroundings.

• Perform required environmental monitoring in the Grade A and B rooms.

• At the end of the batch, aseptically disconnect the bulk tank from the filling line.

• Perform end of batch environmental monitoring sampling.

• Clear the vial wash station, depyrogention tunnel and the filling line of components.

• Disassemble the filling line and remove interchangeable parts for cleaning and sterilization.

• Complete the post-fill disinfection of the vial wash, and filling line.

Environmental Monitoring:

• Perform environmental (viable and non-viable) monitoring in Aseptic Processing Area and adjacent rooms as per SOP, which includes Grade A, B, C, and D classification.

• Ensure that each sample is identified with the following information: Date, Time, Individual being sampled, Sampler, and Sample location.

• Enter EM samples into tracking database prior to submission to QC labs.

• Deliver EM plates to QC lab for incubation.

• Adhere to the disinfection procedure when transporting EM material through different room classifications.

• Perform relative humidity and temperature monitoring to ensure that the environment is within the validated range for the filling process.

Cleaning and Disinfection​: 

• Prepare cleaning reagents for required cleaning of the Aseptic Processing Area and adjacent rooms (Grade A, B, C, and D).

• Ensure that cleaning equipment are sterile and verify that the items have not expired prior to use.

• Ensure that cleaning is performed from the highest level of classification.

• (Grade A) to the lowest level of classification (Grade D).

• Perform routine cleaning and disinfection of the Aseptic Processing Area and adjacent rooms.

• During commercial operations perform cleaning and disinfection of the APA prior to the start of the filling setup, after the completion of the filling setup and at the end of the filling process.

• When RABS gloves are changed ensure that it is cleaned prior to installation.

• Disinfect Bulk tank during transport from Formulation to F&P and from the unclassified area into the fridge (Grade D) and documented in applicable BPR and logbook.

General Duties:

• Prepare media for Aseptic Processing Simulation Study (APSS).

• Receive bulk tanks from Formulations to Filling & Packaging and maintain pressurized system of the tank if required.

• Maintain qualification of Labeling and Packaging activities in order to perform job duties m L&P in the absence of Filling Operations

• Perform filling activities pertaining to the ISO Certification and smoke study.

• Complete 5S activities on the shop floor.

• Train new Filling Operators on the shop floor.

​Minimum Qualifications:

• Minimum 2 years College Diploma in Science, Industrial Pharmaceutical.

• Minimum (1) year of relevant work experience.

• Knowledge of Aseptic Processing & Aseptic Gowning

• Well-versed with cGMP, Health & Safety.

• Strong Mechanical and Computer Skills

• Good Interpersonal Skills, Communication and Problem-Solving Skills.

Hours Of Work:

• Inclusive from Monday to Friday 3:00 p.m. - 11:00 p.m.

​

​This is subject to change at any time and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

Mandatory Application Requirement: Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time you submit your Workday application, otherwise your application will not be considered for this position

This position is for a current vacant role that we are actively hiring for.​

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.

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