Validation Expert* MS&T

Open for hire at one of the following locations –  Singapore. - Job ID: 6312 

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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Validation Expert* MS&T 

Validation Expert is the subject matter expert in validation processes in ensuring products/processes meet regulatory requirements and quality standards. The incumbent will support all operational aspects of MS&T department including technology transfer, process monitoring/support, change control and deviation closure. Your main responsibilities are:

• Develop, implement and manage the site process validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
• Collaborate with cross functional teams to define the interfaces to equipment qualification / utilities qualification, system qualification and analytical method validation.
• Establish and maintain the 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. Provide technical expertise for pre-validation / validation strategy.
• Author or reviewer for routine 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 are defined and taken in case of trends or deviations. Reviews risk assessments for CPV.
• Lead and drive investigation for validation related matters and implement corrective and preventive actions.
• Support the operations team to ensure that all batches are produced safely, on time, and in compliance with manufacturing specifications and quality requirements.
• Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards.
• Initiate, drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety and efficiency.

What you have to offer.

• BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemistry, or equivalent scientific / engineering degree.
• Proven relevant experience in validation role in manufacturing/MS&T department within bio/pharmaceutical industry
• Good knowledge in vaccines process development/manufacturing/fill and finish would be an advantage.
• Knowledge of the current regulatory requirement and good understanding for guidance document for instance FDA/ICH/EMEA/cGMP
• Hands on experience in project management, validation activities, GMP expertise and good understanding of working in GMP environment.
• Ability to adapt to changing priorities effectively and work at the start-up environment.
• Excellent communication skills and ability to effectively collaborate in dynamic, cross functional matrix environment.

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

We are looking forward receiving your application.

*BioNTech does not differentiate on the basis of 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!
 

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