Vacancy title:Head of Engineering Compliance
[
Type: FULL TIME ,
Industry; Engineering,
Category: Information Technology]
Jobs at:BioNTech SE
Deadline of this Job:30 June 2022
Duty Station:
Within Rwanda , Kigali, East Africa
SummaryDate Posted: Thursday, June 22, 2022 , Base Salary: Not Disclosed
Similar Jobs in RwandaLearn more about BioNTech SE BioNTech SE jobs in RwandaJOB DETAILS: Head of Engineering Compliance
Who We AreWe 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 BioNTainersWe 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 YouThe 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 ComplianceAlong 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 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
EducationWhat you have to offer.
• Completed academic degree (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.
Benefits & Compensation.We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
Work Hours: 8
Experience in Months: 60
Level of Education:degree
Job Application procedureApply 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.
We are looking forward receiving your application.• 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!
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