Validation Specialist MS&T
Melbourne, Australia | full time | Job ID: 10647
About the role:
As Validation Specialist MS&T, you will be the subject mattery expert in validation processes (PQ/PPQ phase and continued/on-going phase) in ensuring products/processes meet and continue to meet with the regulatory requirements and quality standards. The incumbent will support all validation and operational aspects of MS&T / Validation department includes (but not limited to), technology transfer, process monitoring/support, change control, deviation investigation/closure and implementation of continuous improvement initiatives.
Your contribution:
- Develop, implement, and manage site process validation, cleaning validation, and revalidation strategies to ensure compliance with cGMP, quality requirements, and Regulatory Authorities' expectations.
- Collaborate with cross-functional teams to define interfaces for equipment qualification, utilities qualification, system qualification, and analytical method validation.
- Establish and maintain the Validation Master Plan (VMP) for process and cleaning validation, ensuring all manufacturing and cleaning processes are validated and maintained as per requalification schedules.
- Participate in product transfers and launches, liaise with technical development, and provide technical expertise for pre-validation and validation strategies.
- Author, review, and execute validation protocols, reports, Master Batch Records (MBRs), change controls, and ensure compliance during shop floor execution.
- Develop local procedures, templates, and strategies for ongoing process and cleaning verification, annual monitoring, and risk assessments for continued process validation (CPV).
- Support investigations related to validation matters, implement corrective and preventive actions, and ensure timely production of compliant batch documents.
- Contribute to audit inspections, ensure inspection readiness, and maintain compliance with regulatory requirements, GMP, and industry standards.
- Drive and implement continuous improvement initiatives to optimize processes, enhance product performance, and achieve operational excellence in quality, safety, and efficiency.
A good match:
- BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemistry, or equivalent scientific / engineering degree.
- Preferably more than 5 years of working experience in pharmaceutical or biotechnology industry
- 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.
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.