Head* of Engineering Compliance
- BioNTech Careers
- Work experience
- Research, development, teaching
We are a global immunotherapy company. Our 3,000+ colleagues globally are committed to improving the health of people worldwide with our fundamental research utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We leveraged our mRNA technology to develop a COVID-19 vaccine which became the first mRNA drug approved for human use.
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”. The aim is to build a regional manufacturing network in Africa, with Africa, for Africa.
Why we need you:
The BioNTainers will be equipped to produce a range of mRNA-based vaccines targeted towards the needs of African Union member states. You will become part of the regional staffing team, driving the establishment of the regional African end-to-end mRNA manufacturing network.
Head* Engineering Compliance
team. The site engineering is in charge to host and execute the local repair, maintenance,
calibration, qualification and automation.
The site engineering team ensures equipment availability in GMP compliant manner. The
mRNA manufacturing suites and its periphery are automated (PCS 7 SIEMENS for Pro-
cess, BMS, EMS, MES) and host standard biotech unit operations (AHUs, Bioreactors,
TFF, Filtration skids, etc. pp.)
Your main responsibilities are:
- Responsible to lead a team of compliance and C&Q engineers
- Business owner for site specific engineering SOPs
- Execution of commissioning and qualification for equipment, utilities and clean rooms
- Definition and Implementation of Change Controls, CAPAs
- Deviation management
- Build and grow the compliance team on site
- SPOC for audits
What you have to offer.
- Completed academic degree (B.Sc./M Sc.) with major in process engineering, mechanical engineering, or biotechnology
- At least 3-5 years of engineering experience in the pharmaceutical industry
- English fluent spoken and written
- German & French highly appreciated
- High degree of GMP know-how for pharmaceutical operations
- Extensive Commissioning, Qualification and Validation knowledge and professional experience required
- Very good planning and organizational skills
- Ability to work without supervision and to demonstrate job ownership
- Pronounced team and communication skills
- Analytical and concept-based thinking and acting
- GMP-related experience is a must
- Strong industry network to equipment vendors etc.
Benefits & Compensation.
How to apply.
- Only applications sent via our online form shall be considered.
- Only Candidates with the right qualifications and relevant experience shall be shortlisted and
- Incomplete applications shall be rejected
- Please note that BioNTech will do a background check during the hiring process (criminal record certificate) in case you do not provide
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!