Associate Operation Technician

About Company

Job Requirements

About the opportunity: The Manufacturing Operations teams are the people that make our client’s products. Working in the manufacturing plants with a “Safety First, Quality Always” mindset, they strive for continuous improvement. The team works in the local plant connected to the global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. What will you do: As a technician, you will join one of the teams who manufacture the client’s medicines. The environment that these teams work in is a clean room environment doing filling and inspection of sterile vials. Our client is proud of being a diverse organisation with an even split of genders at a technician level within Biotech. As part of the continual evolution of the operations, you will be joining our newly created Inspection & Support Team. The core responsibility of this team will be to perform the vials inspection and routine EM sampling. This team will work normal office hours (8am to 5pm, Monday to Friday) but is expected to step up to support the shift team on overtime if the business need arises. The main shift team consists of approximately 10 people per shift working on a 24x7 shift pattern. The shift team focuses on the operations related to the filling of the vials which include Part Prep/Autoclave, Formulation, and Filling. Job responsibilities: Routine operation core activities include completing batch documentation as required including raising of exceptions in a data integrity-compliant manner. You will perform in-process sampling on semi-finished drug products. You will perform visual inspection, labeling, and packaging on semi-finished drug products. You will perform all tasks in accordance with the standard operating procedures and maintain strict compliance with GMP at all times. You will perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing, including bioburden sampling and water sampling. You will perform cleaning and upkeep of the Grade C & D cleanrooms and production equipment. Other support activities include setting up and operating pharmaceutical production equipment including high-speed filling lines for sterile injectables, robotic technology, compounding panels, and automatic CIP/SIP. You will dispense, formulate, and fill active biological product batches as required to meet the production schedule. You will perform microbial sampling and swabbing of rooms and equipment. You will perform filter integrity testing using an automatic filter integrity test unit. You will prepare equipment including loading and starting of sterilisation cycles in autoclaves. For event and atypical investigations, you will report QNs/deviations if any. You will participate in SHE, Business Compliance, cGMP, and compliance matters where applicable. You will be responsible for escalating operations issues to the Lead Technician or Shift Manager when required. For continuous improvement, you will be responsible to participate in Kaizen events in pharmaceutical operations in accordance with Kaizen plans when assigned.