Senior Production Operator

Melbourne, Australia   |   full time   |   Job ID: 10515 

The Senior Production Operator will play a key role in the execution of manufacturing activities for Drug Substance (DS) and Drug Product (DP) and Filling within a GMP-compliant clinical manufacturing environment. This position involves operating complex equipment, ensuring compliance with quality standards, mentoring junior operators, and contributing to process improvements. The Senior Production Operator will act as a subject matter expert (SME) in manufacturing processes and support the team in achieving production goals. 

Your main responsibilities are:

Project phase:

• Support commissioning and qualification tasks where required. 
• Author process equipment operations and other related manufacturing related SOPs and documentation.
• Review / develop and provide operability feedback process automation recipes with engineering team.
• Review and provide operability feedback on Single Use Systems (SUS) used in process equipment.
• Review / develop and provide operability feedback MES recipes that minimize human error.
• Prepare for the site’s GMP readiness 

Routine phase:

• Execute manufacturing activities for Drug Substance (DS) and Drug Product (DP), including filling, while operating, monitoring, and troubleshooting equipment according to established procedures and GMP guidelines.
• Perform in-process checks and sampling to ensure product quality and compliance with specifications, and accurately document all manufacturing activities.
• Ensure compliance with GMP, quality, safety, and work regulations during all manufacturing activities, maintaining cleanliness and organization of production areas in line with GMP standards.
• Identify, report, and support investigations into deviations, non-conformances, or equipment malfunctions, assisting in implementing corrective and preventive actions (CAPAs).
• Collaborate with the Production Manager and cross-functional teams to ensure smooth production operations, communicating issues or observations that may impact production quality, timelines, or efficiency.
• Provide feedback and suggestions to improve manufacturing processes and efficiency, assisting in the implementation and monitoring of process improvements and CAPAs.
• Review manufacturing documentation for accuracy, completeness, and compliance, and support the creation and review of GMP-relevant documents such as SOPs and deviation reports.
• Mentor junior production operators, providing guidance and training on processes and GMP requirements, and assist in onboarding and training new team members.

What you have to offer:

• A minimum of 5+ years of experience in GMP-regulated pharmaceuticals manufacturing operations.
• Diploma / Bachelor’s Degree in Science, Chemical Engineering, life sciences or equivalent field is a desirable
• Strong knowledge of DS/DP, Filling processes, including filling, capping, labelling, and packaging equipment.
• In-depth understanding of GMP regulations and quality standards.
• Understanding of aseptic techniques and sterile manufacturing requirements.
• Ability to follow detailed instructions and procedures with precision.
• Proven ability to mentor and train junior team members.
• Strong analytical skills to identify and resolve manufacturing issues.
• Excellent communication and teamwork skills to collaborate effectively across departments.

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 is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.