This position is mainly responsible for building production lines based on platform products, transferring processes, verifying products, and providing related training. At the same time, it assists in converting production-related documents, building production systems, and ensuring the effective implementation of the company’s transfer strategy.
Responsibilities
- Based on the design output, organize the establishment of suitable product manufacturing processes and take the lead in process and product validation.
- Assist in the arrangement of transfer work, production data processing, and related coordination work.
- Setup and update work instruction and manufacturing process flow, set up the standard for manufacturing process.
- Review procedures and specifications relating to the production area.
- Responsible for assisting in the selection of production line equipment/raw materials and completing related validation. Assist in the implementation of the ERP system and guide the establishment of BOM in the system.
- Support production to solve manufacturing problems, constantly improve and optimize production process to reduce costs, losses, time, rework, facilitating process and maintaining product quality.
- Responsible for manufacturing process training, manufacturing process management, supervision and technical service on production site.
Qualifications
- Bachelor degree or above in Biology, Pharmaceutical, Life Science or related.
- Minimum 2 years or more relevant manufacturing working experience in Biotechnology-related industries.
- Familiar with medical device industry regulation.
- Experienced in quality system of ISO 13485 and GMP is preferred.
- Fluent in English and Bahasa, verbal and written communication
- Wiling to work in Cikarang
Pertanyaan dari perusahaan
Lamaran kamu akan mencakup pertanyaan-pertanyaan berikut:
- How many years’ experience do you have as a Process Engineer?
- How would you rate your English language skills?
