C&Q Engineer
Melbourne, Australia | full time | Job ID: 10603
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 leading the commissioning and qualification activities for equipment, automation systems, facilities and utilities in a biopharmaceutical manufacturing environment. This role ensures that all C&Q activities comply with regulatory requirements and company standards while supporting new capital projects and continuous improvement.
Your main responsibilities are:
- Support regulatory audits and inspections, addressing C&Q-related observations and corrective and preventive actions.
- Support the development of User Requirements Specification documents.
- Partner with local and global colleagues in engineering, manufacturing, QC, QA and SHE to ensure compliance and operational readiness.
- Manage external contractors, consultants, and vendors supporting C&Q activities.
- Manage C&Q documentation in electronic document management systems (e.g. Veeva, COMOS)
- Drive continuous improvement initiatives to enhance efficiency and compliance in C&Q processes.
- Lead minor capital projects as required including design, procurement, installation, commissioning and qualification.
- Comply and cooperate with site SHE requirements such as use of PPE usage, incident reporting and other requirements securing the safety, health and welfare while at work.
What you have to offer:
- Degree in Engineering/Science or related studies.
- Minimum of 5 years’ experience in commissioning, qualification, and validation in a GMP-regulated biopharmaceutical or pharmaceutical manufacturing environment
- Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies.
- Expertise in regulatory compliance (FDA, EMA, PIC/S) and industry guidelines (ISPE, ASTM E2500, GAMP).
- Strong leadership and project management skills.
- Effective communication and interpersonal skills.
- Ability to solve problems and continuously improve processes based on root cause analysis.
- Ability to manage multiple priorities in a fast-paced environment
- Able to work independently, self-starter, self-motivated and task oriented.
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.