Senior Automation Engineer
Melbourne, Australia | full time | Job ID: 10602
BioNTech is establishing an mRNA research and manufacturing facility in Melbourne based on its modular mRNA manufacturing approach called BioNTainers that will support R&D and the evaluation of mRNA vaccine candidates in clinical trials in Australia, with the aim of strengthening Australia’s mRNA ecosystem. In this exciting role, you will be responsible for implementing, validating and maintaining automated systems planned for deployment at our new manufacturing site. This role involves working closely with global automation and IT colleagues to ensure the efficient and compliant operation of automated equipment and systems.
Your main responsibilities are:
- Participate in the development of automation solutions for biopharmaceutical manufacturing processes, including production, packaging, and quality control.
- Collaborate with stakeholders to understand their requirements, including continuous improvement opportunities, and translate them into technical specifications.
- Oversee the installation, configuration and commissioning of automation systems, ensuring adherence to project timelines and budgets.
- Monitor and maintain automated systems to ensure uninterrupted operations including the building management system, process automation and environmental monitoring systems, manufacturing execution system, data historian, security systems.
- Support IT with the system administration of local platforms and computerized systems in engineering, manufacturing and QC.
- Support troubleshooting, maintenance, upgrades, data migration and decommissioning.
- Manage the cybersecurity requirements and work closely with IT to implement a safe working environment free from cyber threats.
- Lead local activities for computer system commissioning (FAT/SAT), qualification (IQ/OQ) and validation (CSV), for automation systems deployed at the new manufacturing site.
- Ensure that automation solutions comply with regulatory requirements, GMP (Good Manufacturing Practice) standards, and other relevant regulations.
- Create lifecycle, validation and decommissioning documentation for computer systems according to GAMP 5 regulation.
- Conduct risk assessments of automated systems to identify potential hazards and implement risk mitigation strategies.
- Investigate deviations or non-conformances related to automation systems and implement corrective and preventive actions.
What you have to offer:
- Bachelor of Science in Computer Science or related field.
- At least 5 years' experience in Manufacturing, Engineering or Execution Systems/Automation, preferably within the biopharmaceutical or pharmaceutical industry
- Adept knowledge of automation technologies including Siemens PCS7, BMS, MES, data historians and industrial networking protocols.
- Familiarity with regulatory requirements and standards governing pharmaceutical manufacturing processes.
- Experience with test protocols and executions eg. IQ/OQ/PQ, test scripts with relevant key deliverables such as plan, report, deviation, change control and industry best practices etc.
- Experience in start-ups, commissioning & qualification (CSV) of automation and process control systems.
- Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
- Excellent problem-solving skills and ability to troubleshoot complex technical issues.
- Effective communication and teamwork abilities, with the capacity to collaborate with cross-functional teams.
- Attention to detail and commitment to safety, quality and compliance.
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.