Production Engineer (Validation)

• 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.