Senior Technical Manager Asceptic Fill & Finish
Kigali, Rwanda | full time | Job ID: 10549
As Senior Technical Manager Aseptic Fill and Finish you will be responsible for the filling line and all supporting equipment operate as required. All filling and packaging requirement are completed successfully and all supporting documentation is completed in line with BioNTech procedures. This role is responsible for driving continuous improvement initiatives and as a Subject Matter Expert (SME) on filling during regulatory inspections, developing procedures and ensuring operators training is completed and kept up to date for Aseptic filling process. The Senior Technical Manager will collaborate with Quality and Engineering teams, and providing technical leadership for new process implementation initiatives.
Your main responsibilities are:
- Oversee and operate equipment for Aseptic filling, sterilization operations in the cleanroom areas, ensuring adherence to GMP, safety, and quality standards
- Establish and maintain quality processes for vial filling, visual inspection, labelling, and packaging operations.
- Perform and oversee the operation, cleaning, and setup of aseptic filling machine and related equipment to maintain sterility.
- Act as a Subject Matter Expert (SME) for aseptic filling operations, providing technical guidance and support during regulatory inspections
- Lead site qualification of filling equipment and continuous process validations and ensure GMP requirements are met.
- Ensure adherence and compliance with batch records and SOPs
- Works closely with the production staff to troubleshoot process and equipment problems while ensuring appropriate and proactive internal stakeholder engagement.
- Ensure timely and efficient preventive and corrective maintenance activities are carried out as per maintenance schedule.
- Ensures the proper processes are in place for GMP and Safety training of staff, with a focus on Aseptic filling operations
- Provide technical training to operators, demonstrating proper aseptic techniques and conduct assessment and qualification of operators in line with BioNTech procedures.
What you have to offer:
- Master’s and/or Bachelor’s in Engineering or Science discipline
- 7+ years of GMP pharmaceutical manufacturing environment
- Significant experience in Aseptic filling process
- Expertise in GMP Aseptic filling operations especially in Biopharmaceuticals
- Strong understanding of aseptic processing, cleanroom environments, and associated equipment.
- In-depth knowledge of GMP, FDA and other regulatory requirements for pharmaceutical sterile filling processes.
- Strong organizational skills
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
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”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.
Benefits for you:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending 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 via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.