Job Title: Service Operator
Department: Manufacturing Unit
Reporting To: Process Team Lead or Shift Lead
Job Purpose:
Execute assigned manufacturing tasks and activities according to production schedule incompliance with the relevant GMP, safety and environmental guidelines.
Perform routine operational support activities according to the manufacturing process and schedule and enable the timely production of product with the quality and quantity.
Major Accountabilities
Domain specific main activities
- Participation to the manufacturing support processes
- Execution of all assigned activities according to production schedule and in compliance with the valid GMP, work, operating, environmental and safety instructions and guidelines.
- Batch record review on time and without error (production part)
- Proper and timely cleaning, preparation and sterilization of the production equipment andproduction rooms
- Equipment parts management (punch, sieve etc.)
- Support on cleaning and changeover
- Work permit coordination where applicable
- Material movement in shop floor (including dispensing)
- Waste material management and pre-treatment of liquid waste streams) at shop floor
- Raw material ordering (filling daily tanks of solvents, Kanbans, packaging materials)
- Responsible for production area housekeeping (cleaning, tidiness, 5S...)
- Comply with and enforce health, safety and environment rules and guidelines (HSE)
- Apply and enforce the current GMP rules
- Sampling, aliquoting, distribution and performing of in-process controls
- Implementation of the delegated environmental monitoring for clean rooms and the delegated sampling of ultrapure water and pure steam if applicable
- Organization of immediate measures in the event of a fault, reporting abnormalities to the manager; experts and operational QA
- Ensure / monitor the proper functioning of the equipment in order to detect early signs of anomalies. Take appropriate action in the event of a malfunction.
- Documentation of the activities according to GMP regulations
- Manage the consumables supply necessary for the proper functioning of operations
- Sort and eliminate waste related to production activities
- Daily checks of manufacturing equipment, support devices and rooms
- Clearly and precisely document the necessary remarks in the batch records
- Participate in the production schedule building-up (report delays, wrong activities duration...)and comply with it
- Commitment and participation to operational excellence and continuous improvement
- Proper handling of biological and chemical substances in the production plant
- Participation in all training relevant to the position, maintenance of the relevant training evidence
- Advancing and maintaining an HSE-compliant environment: reporting near misses
Non domain specific main activities
- Perform manufacturing related ERP transactions/activities
- Perform IPC related activities in LIMS or ERP system
- Participate in investigations in the context of deviations, OOS, OOE, etc.
HSE and Quality
- Promote and improve the Safety and Quality cultures
- Apply in practical the upgrading, and the improvement of Safety and Quality on the shop floor
- Ensure overall inspection readiness for area of responsibility
- Supervision in their area, incident reporting and action follow-up at shop floor level
- Ensure the availability and proper use of Protective Equipment
- Comply with safety, cleanliness and tidiness rules (housekeeping, 5S)
- Detect and report potential accident, risks and propose solutions
- Preparation and participation to internal HSE audits
Operational Excellence and continuous improvement
- Willingness to continuously improve and analyze weak points
- Suggest improvement actions (organization, process, safety, hygiene, etc.) at shop floor
- Manage / participate in continuous improvement projects in line with strategic objectives
Education: Vocational qualification required in Chemical Engineering, Logistics, Computer science or equivalent experience
Languages: Proficient in site local language
Experiences: Experience(preferable) in chemistry / food / pharmaceuticals / biotech / aseptic manufacturing or projects
Role: Contract role
Operating shift: 12 hours of Rotating shift
