Process Specialist (all genders)
Kigali, Rwanda | full time | hybrid | Job ID: 7890
The Process Specialist is the technical expert responsible for providing technical support during the manufacturing and production of pharmaceutical products (vaccines). MS&T Process Specialist provides technical support for cGMP activities such as tech transfer, process engineering, process validation, process monitoring, and computer system validation (CSV) in the cGMP manufacturing facility. The role is to ensure the scientific and technical integrity of the data generated during the manufacturing process and product throughout the lifecycle.
The Process Specialist is responsible for maintain data for the organizations while also protecting the data assets. The incumbent will support all operational aspects of MS&T department includes, technology transfer, process monitoring/support, change control and deviation closure.
Your main responsibilities are
- Subject Matter Expert for pharmaceutical manufacturing process technologies including any pilot scale, scale up or down, and Design of Experiments (DoE)
- Provides primary (on floor) production support. Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost
- Provides technical support for the investigation and resolution of deviations and atypical events by partnering with Quality Assurance to ensure consistent quality standards are maintained
- Assure regulatory compliance and technical feasibility of proposed changes. Conduct risk assessment and develop mitigation strategies to address potential technical, operational, regulatory challenges during the transfer process and commercial production
- Recommends and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences. Follow up to determine if corrective actions adequately addressed root cause of NC event
- Lead and participate in the definition, selection, and gap assessment of process-specific pharmaceutical equipment and systems. Provide technical expertise for equipment qualification around technologies
- Collaborate with technical development, other sites, and global MS&T network to facilitate transfer of technical knowledge to local
- Develop, review and approve guideline documents, Standard Operating Procedure, technical protocols, and reports
- Demonstrates expertise in the following areas: cGMPs, FDA regulations, mRNA manufacturing processes, manufacturing equipment and utilities
- Drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety and efficiency
- Contribute to all relevant audit inspections and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards
- Excellent documentation of activities in accordance with GMP regulation
What you have to offer
- Bachelors/Masters degree in natural /life sciences or engineering sciences including Pharmacy, Pharmaceutical Technology, Biochemistry, Biotechnology, Chemistry, or equivalent scientific / engineering degree or comparable training
- Proven experience in a technical role such as manufacturing, quality control or regulatory affairs in pharmaceuticals, food and beverage industries
- A good understanding of working in GMP environment is an added advantage
- Proficiency in data analysis and interpretation to drive informed decision
- Solution-oriented & service-orientated way of working
- Very good planning and organizational skills
- Self-motivated work attitude and an ownership spirit for the job
- Ability to adapt to changing priorities effectively and work in a start-up environment
- Strong communication skills and ability to effectively collaborate in dynamic, cross functional matrix
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 Recruiter.
We are looking forward receiving your application.