Validation Specialist (all genders)

Kigali, Rwanda   |   full time   |   hybrid   |   Job ID: 7883 

A Validation Specialist tests and documents the validity and accuracy of manufacturing systems, equipment and processes to ensure products/processes meet regulatory requirements and quality standards. 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

• Developing and executing validation protocols for equipment, processes, and systems used in the manufacturing of pharmaceutical products
• Collaborate with cross functional team to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation
• Establish and maintain Validation Master Plan for process and cleaning validation. Ensure that all manufacturing and cleaning processes are validated, overview on state of validation at site is maintained
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation. Provides  technical expertise for pre-validation / validation strategy
• Develop, review and approve validation protocols and reports, reviews Master Batch Records (MBRs), associated change controls and supports the execution at the shop floor
• Develop the strategy for ongoing process and cleaning verification and annual monitoring strategy that ensures all critical process parameters and quality attributes are monitored or analysed, and actions taken in case of trends or deviations. Reviews risk assessments for Continued process verification (CPV)
• Set local procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments
• Support product investigation for validation related matters and implement corrective and preventive actions
• Support operational teams to ensure that all batches are produced safely, on time, and in compliance with manufacturing specifications and quality requirements
• Participate in audits and inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards
• Drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety, and efficiency
• Documenting validation activities and results in accordance with regulatory requirements, FDA, MCC and BioNTech guidelines
• 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. Identifying and addressing deviations and non-conformances in validation activities

 What you have to offer

• Bachelor´s/Master’s degree in engineering sciences including Pharmacy, Pharmaceutical Technology, Biochemistry, Biotechnology, Chemistry, or equivalent scientific / engineering degree or comparable training
• 3 to 5 years of working experience in pharmaceutical or biotechnology industry
• Hands on experience in validation activities, GMP expertise and good understanding of working in GMP environment
• Require strong analytical skills, attention to detail, and the ability to work collaboratively with other departments
• 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

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.