Engineer - Production (Validation)

2 months ago


Hanoi, Vietnam B. Braun Vietnam Co. Ltd. Full time

**Duties and responsibilities**:

- To assist in the performance and adherence to ISO requirements
- To maintain proper function of data collection used in validations and qualifications per procedure requirements
- To plan and organize the internal and external ETO chamber qualification and validation
- To execute internal customer (R&D, production, engineering) validations for routine production processing and/or engineering studies.
- To generate study documentation and report that related to any validation/experimental study
- To execute product validations as scheduled
- To support in product adoption to sterilization and sterilization management review
- To assist Quality Management on Audit process whenever necessary
- To assist superior on CAPA management process, Risk management, Complaint Handling, Change Control process and other quality issues whenever required
- To support updates to procedures related to their responsibilities
- To undertake any tasks or project delegated by the superior as when and where required
- To support modifications, overhauls, repair, maintenance, or downtimes to minimize disruptions to manufacturing schedules
- To development the team according to define qualification matrix with development plan
- To handle process deviation (Lead for DIR, A3, Non-conformance or CAPA regarding to process)
- To lead for local changes control link to process
- Representation of the process in internal and external audits and committees
- The job function listed is not exhaustive and shall include any responsibilities as assigned by the Supervisor from time to time.

**Professional competencies**:

- Bachelor's Degree or with related working experience. (University Degree/Diploma/Certificate in microbiology technology; chemical technology or automation Engineers.)
- Have at least 3-year-working experience in production environment with similar position. Experience in EO sterilization process validation is added advantage.
- Have lean manufacturing knowledge (6 Sigma - 5S)
- Good knowledge in term of root cause analysis methodology
- Good in making report and presentation skill

**Personal competencies**:

- Good English communication

**What we offer**:
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

**Closing date**:

- 30.04.2023



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