
Posted 16 hours ago
Production Operator
BioNTechProduction Operator
Requirements
Diploma or Bachelor's in Science, Chemical Engineering, or Life Sciences, 5+ years GMP pharmaceutical manufacturing experience, Knowledge of DS/DP processes, Experience with aseptic techniques, Familiarity with MES and automation systems
Skills
GMPMES
About the role
Responsibilities
- Execute manufacturing activities for Drug Substance (DS), Drug Product (DP), aseptic filling, and packaging according to GMP guidelines
- Operate and monitor complex manufacturing equipment and support troubleshooting activities
- Generate, edit, and maintain accurate manufacturing documentation and process records
- Perform in-process checks, sampling, and ensure strict adherence to aseptic techniques
- Support commissioning and qualification tasks, providing feedback on automation recipes and Single Use Systems (SUS)
- Ensure compliance with GMP regulations and escalate any deviations or equipment malfunctions immediately
- Collaborate with Senior Operators to drive process improvements and ensure smooth production workflows
Requirements
- Diploma or Bachelor’s Degree in Science, Chemical Engineering, Life Sciences, or an equivalent field
- Minimum of 5+ years of experience in GMP-regulated pharmaceutical manufacturing operations
- Strong knowledge of DS/DP processes, including filling, capping, labeling, and packaging
- Proven experience with aseptic techniques and sterile manufacturing requirements
- Familiarity with digital manufacturing tools such as MES and automation systems
- Strong analytical skills and the ability to resolve manufacturing issues effectively
- Excellent communication skills and a proactive approach to teamwork
About the Company
BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into life-saving treatments. We focus on addressing high medical needs, such as cancer and infectious diseases, through innovative individualized immunotherapies. Our mission is to make healthcare innovations accessible worldwide through advanced manufacturing solutions.
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BioNTech · Melbourne
