**Work Schedule** Rotational days/weekends **Environmental Conditions** Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed PURPOSE OF POSITION/RESPONSIBILITY:
As directed by the Department Manager and/or Lead, the “Department Injectable Operator” performs the duties and activities listed below for which he/she has been qualified by the appropriate training, in compliance with company and department SOPs and applicable safety regulations. SPECIFIC DUTIES/PRIMARY ACTIVITIES: - Is responsible for the proper use of the personal protective equipment provided for the performance of his/her duties.
- Provides, coordinated by the Lead, for the washing and sterilization through the use of the autoclave of materials required for cleaning and production activities of the department, verifying before unloading the materials to be used the compliance of the sterilization cycle
- Provides for the correct identification of materials to be used for production activities (caps, bottles, ferrules, assemblies, etc.) in accordance with current SOPs
- Manages the flow and sanitization of materials before they enter the department in accordance with current SOPs
- Prepares isolators for the execution of the decontamination cycle, positioning the loading of materials and installing glove extenders before the start of the cycle as per specific SOPs
- Verifies before the start of production activities that the cleaning of the lines involved in processing has been properly carried out, checking the relevant documentation and performing line inspections as per SOP specifications
- Verifies prior to the start of production activities that the decontamination cycle of the isolators involved in processing is in compliance




- Prepares the filtration systems to be used on the filling line for performing integrity tests
- In case of using disposable systems, verifies their integrity before use and proceeds to their proper assembly for filtration and filling activities
- Provides operations on the production machines in the Department following the instructions described on the Batch Record and current SOPs
- Performs periodic checks on the lines as required by the current SOPs
- Ensures the correct operation of the department machines, performing corrective actions in accordance with the SOPs in force
- Handles activities related to chemical and microbiological sampling, drawing up the relevant documentation in accordance with current SOPs
- Also performs mechanical interventions on machines including format change and machine adjustment before production start-up
- Handles the delivery of pallets of finished product to Dispensing or cold storage for products that need to be stored at a controlled temperature
- Performs cleaning of production machines present in the Department at the end of production activities following the instructions described on the Batch Record and current SOPs
- Provides periodic manual cleaning of the lyostat chambers as per the current SOPs
- Provides for the cleaning of class C rooms in the department at the end of Production activities in accordance with current SOPs
- Provides a daily check of consumables (e.g., overalls, gloves and masks for dressing,



sanitizers and sponges for cleaning machines and rooms) to ensure their constant availability for the management of the department.
- Takes care of machinery, materials and work environment, reporting any anomalies to supervisor in a timely manner
- Operates on production lines following the behavioral standards set forth in current SOPs to reduce the risk of contamination
- Complies with dressing procedures described in current SOPs while performing production activities
- Provides periodic integrity testing of gloves installed on isolator lines and RABS systems in accordance with current SOPs
- Provides particle monitoring of the department premises using the appropriate portable systems and in accordance with the manner and frequency described by the current SOPs
- Promptly alerts the Department Lead in case he/she detects anomalies that may generate a delay of scheduled activities or compromise the quality of the processed product (example: systems failures, out of limit of environmental or particle parameters, etc.)
- Handles departmental pallet handling according to the flows required by current SOPs
- Fills out Batch Record and department documentation related to tasks performed REPORTS:
Internal
- Department personnel
- Production Departments
- Quality
- Technical Services External REQUIREMENTS AND QUALIFICATIONS:
(A) ESSENTIALS Education/Diplomas/Training: - Grade 12 Technical and computer skills: - Familiarity with computer systems whose access is regulated by the use of nominal UserIDs and passwords
- Knowledge of aseptic technique Professional Experience: - None if Recent Graduate
- At least one year of experience in similar departments if Graduates Languages: - Italian P

📌 Formulation Technician Ii (Monza)
🏢 Thermo Fisher Scientific
📍 Monza