Job Summary

We are seeking a meticulous and proactive Qualification Engineer to ensure that all processes and equipment within the facility operate safely, efficiently, and in compliance with internal standards and regulatory requirements. This role will focus heavily on evaluating new or existing processes, identifying risks, proposing improvement solutions, and performing qualification activities for new/change equipment and process.

Key Responsibilities

1. Process Evaluation & Improvement

For new processes, ongoing processes, or processes requiring change, the Qualification Engineer will:

Conduct risk assessments to identify potential process failures or quality concerns by FMEA method
Work with cross‑functional teams (QC, Production, Engineering, etc.) to discuss risks, define improvement solutions, and identify root causes.
Implement corrective and preventive actions and ensure follow‑up until closure.
Document findings, create structured reports, and maintain compliance with GMP/ISO standards.

2. Qualification & Assessment of New Equipment

Lead equipment qualification activities (IQ/OQ/PQ) for newly installed machinery.
Review and verify equipment technical specifications to ensure suitability for intended use.
Coordinate with testing, engineering teams, and internal stakeholders during equipment installation, testing, validation, and handover.
Ensure all qualification documentation, including protocols and reports, meets internal and regulatory requirements.

3. Compliance & Documentation

Ensure all activities comply with GMP, ISO, safety standards, and company SOPs.
Maintain accurate and complete qualification files, validation documents, and technical records.
Assist in internal and external audits by providing necessary technical documentation and explanations.
Cross‑Functional Collaboration
Work closely with Production, Engineering, QC, Planning teams to ensure seamless process and equipment readiness.
Provide technical support during process changes, deviation investigations, and improvement discussions.
Other Responsibilities
Support calibration, change control, and deviation investigations where technical analysis is required.
Participate in training sessions and contribute to building best practices for qualification and process evaluation activities.
Perform additional tasks as assigned by the manager.

Qualifications

Bachelor's degree in Engineering, Pharmacy, Mechanical Engineering, Chemical Engineering, or related field.
Experience in risk assessment, equipment qualification, process validation, or quality/engineering in a regulated environment is preferred.
Strong analytical.
Ability to work independently and manage multiple tasks simultaneously.
Good communication skills and ability to collaborate effectively with cross‑functional teams.
Familiarity with GMP, ISO, or similar quality standards is an advantage.

What sets B. Braun apart

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 (to be included for those working in 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!

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To find out more about B. Braun Vietnam just click here

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