C&Q Engineer

Core responsibilities:

• Lead commissioning and qualification activities for equipment, automation systems, facilities and utilities in a biopharmaceutical manufacturing environment
• Ensure all C&Q activities comply with regulatory requirements and company standards while supporting new capital projects and continuous improvement
• Manage C&Q documentation in electronic document management systems (e.g. Veeva, COMOS)
• Lead minor capital projects including design, procurement, installation, commissioning and qualification

This role supports the establishment of mRNA research and manufacturing facilities in Australia to strengthen the mRNA ecosystem, with the broader goal of improving healthcare by making innovations accessible worldwide through regional manufacturing networks.

Required qualifications:

• 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
• Expertise in regulatory compliance (FDA, EMA, PIC/S) and industry guidelines (ISPE, ASTM E2500, GAMP)
• Strong leadership and project management skills with ability to manage multiple priorities in a fast-paced environment

BioNTech offers competitive remuneration packages determined by the specific role, location of employment, and the selected candidate's qualifications and experience. The company is committed to the wellbeing of team members and offers a variety of benefits in support of a diverse employee base.