Production Engineer (Validation)

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

•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.
•Good English communication
•Have lean manufacturing knowledge (6 Sigma - 5S)
•Good knowledge in term of root cause analysis methodology
•Good in making report and presentation skill

Cập nhật gần nhất lúc: 2023-05-06 11:40:04