Melbourne, Australia | full time | Job ID: 11432
About the role
As a Production Operator at BioNTech, you will play a vital role in our mission to pioneer individualized immunotherapies and make a significant impact on global health. Your work will be central to executing manufacturing activities for Drug Substance (DS) and Drug Product (DP) in a GMP‐compliant clinical environment. Operating complex equipment and ensuring adherence to quality standards, you will contribute directly to achieving production goals and advancing process improvements.
Your Contribution
* Support commissioning and qualification tasks, including providing operability feedback on process automation recipes, Single Use Systems (SUS), and MES recipes
* Generate, edit, and maintain process equipment, operations, and other manufacturing documentation
* Execute manufacturing activities for DS, DP, aseptic filling, and VI/Pack according to established procedures and GMP guidelines
* Operate and monitor manufacturing equipment while supporting troubleshooting activities
* Perform in‐process checks, sampling, and accurate documentation of all manufacturing activities
* Ensure compliance with GMP regulations, elevate deviations or malfunctions, and maintain cleanliness in production areas
* Collaborate with Senior Operators to ensure smooth operations and provide feedback for process improvements
A Good Match
* Diploma/Bachelor's Degree in Science, Chemical Engineering, Life Sciences or equivalent field is desirable
* Minimum of 5+ years of experience in GMP‐regulated pharmaceutical manufacturing operations
* Strong knowledge of DS/DP processes including filling, capping, labeling, and packaging equipment
* Experience with aseptic techniques and sterile manufacturing requirements is highly advantageous
* Familiarity with digital tools such as MES and automation systems used in manufacturing environments
* Analytical skills for identifying and resolving manufacturing issues effectively
* Excellent communication skills with a proactive approach to collaboration and teamwork
What we do with the BioNTainers
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA‐manufacturing facilities based on a container solution called "BioNTainers". Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end‐to‐end mRNA manufacturing solutions.
Benefits for you
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which are determined by the specific role, location of employment and also the selected candidate's qualifications and experience.
#J-18808-Ljbffr