Validation Specialist*

Join our team of pioneers!

Who we are:
We are a global immunotherapy company. Our 5,000+ 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 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.

Validation Specialist* 

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

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

How to apply: 

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.
• Please note that BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

www.biontech.com