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The Sr. Associate, Manufacturing Science & Technology Engineering, is primarily responsible for leading research initiatives and optimizing project outcomes by developing and evaluating new production materials, equipment, and technologies. This role demands advanced technical skills, problem-solving abilities, and strict adherence to procedures.
Job responsibilities:
- Collaborate with process owner, Process Control and Technical Stewardship team to establish critical process parameter from manufacturing process and ensure robust control in place to sustain manufacturing process.
- Support/ lead quality investigations resulting from internal non conformance
- Responsible for supporting and improving existing processes through process monitoring, analysis, control, and the application of engineering principles.
- Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through appropriate documentation and supporting at the receiving site.
- Partnership with Validation team for validation strategy alignment.
- Initiate and/or lead (case by case) the change controls to its products and related processes.
- Ensure alignment of (regulatory) timelines for technical changes (eg.DS), transfers or launch, major deviations.
- Lead/ support material changes/ 2nd source material feasibility study and qualification activities to sustain business/operation continuity.
- Support/ lead continuous improvement project to improve operation efficiency, effectiveness and improve product quality.
Minimum requirement:
- Minimum 5 years of working experience
- Bachelor/Master's in Chemistry / Science/ Engineering
- Working experience in pharmaceutical/medical device/regulated manufacturing plant
- With risk management and product life cycle management experiences in
pharmaceutical/medical device/regulated manufacturing plant
- 3 years project management experience in leading cross functional team
- Understanding in ISO 13485 & ISO 14971, MDSAP & QMSR
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