Summary
Date Posted: Thursday, February 16, 2023 , Base Salary: Not Disclosed

JOB DETAILS:
Qssr-Bnt-Qce-Qualification & Compliance Engineer
Q-Sourcing Servtec Group Rwanda
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 Summary:
Along with the growth of BioNTechs global footprint, we are 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:
• Responsible to lead a team of external compliance and C&Q engineers from service suppliers
• 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
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.

Job Experience: No Requirements

Work Hours: 8

Level of Education: Bachelor Degree

Job application procedure
Apply now and simply send 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 by using our online form.

Please note:
• 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.


All Jobs

QUICK ALERT SUBSCRIPTION