Process Development - In Vitro Diagnostics

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 the In Vitro Diagnostics (IVD) or Biotechnology-related industries.
• Understanding of regulation in the medical device industry.
• Experienced in quality system of ISO 13485 and GMP is preferred.
• Fluent in English & Bahasa (verbal and written communication)
• Willing to work in Cikarang area