BioNTech
JOB TITLE: HEAD OF ENGINEERING COMPLIANCE
Who we are:
As BioNTech, 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 toward 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.
Role Purpose
Along with the growth of BioNTech’s global footprint, BioNTech is staffing a new site engineering 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 Process, BMS, EMS, MES) and host standard biotech unit operations (AHUs, Bioreactors, TFF, Filtration skids, etc. pp.)
Tasks:
Head Engineering Compliance as Ass. Director Automation (Level 7 / 8)
- 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
- Training at our host sites (Mainly in Marburg and partially in Mainz) in the below mentioned areas / tasks for the initial 3- 6 months.
Qualifications:
Education:
Completed academic degree (Dipl.-Ing. TU/ FH, B.Sc./M Sc.) with major in process engineering, mechanical engineering, or biotechnology
Professional experience:
- At least 3-5 years of engineering experience in the pharmaceutical industry
Languages:
- English fluent spoken and written
- German & French highly appreciated
Competencies:
- 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.
Application procedure:
Interested and qualified applicants should submit their applications through the link below.
https://qsourcingservtec.applytojob.com/apply/9NVtZy840z/QSSKBNTHECHEAD-OF-ENGINEERING-COMPLIANCE
Note:
Only shortlisted applicants will be contacted.
Q-SOURCING SERVTEC IS AN EQUAL OPPORTUNITY EMPLOYER. ANY SOLICITATION WILL LEAD TO DISQUALIFICATION.
