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:
- Competitive salary and attractive annual bonus
- Annual Package Bonus
- Guaranteed 13th month salary
- Company health insurance
- Responsibility allowance
- Service award
- Company canteen or lunch allowance
- Exciting company engagement activities
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. Apply now!