About this role
Why this role matters: As a Validation Engineer - QM (Validation & Risk Assessment), you will coordinate and maintain all (re)validation activities across production processes, ensuring compliance with quality requirements and supporting the reliability and effectiveness of manufacturing operations. Coordinate and maintain (re)validation activities for production processes. Ensure validation activities are completed in accordance with local and global procedures. Support process consistency, product quality, and operational compliance. Contribute to risk-based decision making within manufacturing operations.
How you will make an impact
- 1) Qualification & Validation 1.1) Responsible make (Re)validation protocols/reports 1.2) Coordinate with related department to commit with expected validation timeline 1.3) Involve and perform validation during Change control activity 1.4) Involve and perform validation during Project execution 1.5) Follow requirement of local/global SOP for (re)validation process and sharing ith with local team
- 2) Risk assessment 2.1) As team member for Process risk analysis 2.2) As team member for Equipment risk analysis 2.3) Undertood and sharing risk analysis concept to related departments: Method, Measurement, Action, Requirements…
- 3) Others task 3.1) Create/revise local SOP according to requirement in global SOP/ ISO/ regulations 3.2) Perform training/sharing SOP for Production/ QC/ IE to follow up.
3.3) Make the training plan for new member/FSU and companion with them during development program What sets you up for success: Bachelor's Degree with a technical background. (required) Knowledge of validation principles and practices. (required) Understanding of risk management and risk analysis methodologies. (required) Familiarity with ISO 13485, ISO 9001, ISO 11135, and ISO 11607 standards is an advantage.
- Experience in ETO sterilization process validation is preferred.
- Experience in validation activities within medical device manufacturing is preferred.
- Good English communication skills.
- Strong communication, presentation, teamwork, and MS Office skills.
What you will enjoy along the way: B. Braun Vietnam, a subsidiary of one of the world's leading healthcare technology companies, B. Braun Melsungen AG Group, now operates one of the largest medical complexes in Vietnam and has become a prestigious trademark in Vietnam healthcare market. With more than 1,400 employees nationwide and proud to be one of ‘Best Companies to Work for’ in Asia, we develop high quality “made in Vietnam” products widely being used and appreciated in international and domestic market.
Our product offering ranges from hospital consumables to high-tech medical devices and equipment. Every service provided by B. Braun Vietnam incorporates the entirety of our knowledge and skills, the company's deep understanding of users' needs and extensive expertise. Our mission is to PROTECT and IMPROVE the health of people around the world. We welcome you to join the B. Braun family and share your expertise!
What can we offer you?
- Competitive salary and attractive annual bonus Guaranteed 13th month salary Company health insurance Responsibility allowance Service award Company canteen or lunch allowance Company bus for those based in Hanoi Plant Exciting company engagement activities What’s next?
Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience.
Join us and be part of something extraordinary! We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here Check us out on Social Media! B. Braun Group LinkedIn B. Braun Group YouTube To find out more about B. Braun Vietnam just click here At B. Braun, together means better.
We believe that diversity makes us stronger. That is why we are committed to creating an inclusive workplace where everyone feels respected, valued, and empowered to make a meaningful impact. We welcome applications from people of all identities, backgrounds, and perspectives. Join us.