Process Engineer

Job Description

The Position

Support operation team to ensure the operation performance achieve the target with the right procedure by providing technical expertise and execution on process validation, cleaning validation, change control, quality risk management, technical specification on material and component, and new product or line extension market, projects, continuous improvement activities.

Support and/or supervise Operation team on investigation of any atypical or deviation in the product, process or equipment, material and component and develop operational team by training as per requirement to support the technical operation activities.

Responsibilities

• Execute process validation, cleaning validation, and equipment qualification that impact to quality of product by preparing, executing, reporting these activities including its periodic monitoring and its documentation.
• Involve in tooling/engineering trials, installation, commissioning, and validation activities as required.
• Execute change control process both internal and external site including change from supplier.
• Support and/or supervise operation team on investigation of any atypical or deviation result related to technical that happened in the product, process, equipment, material, or component.
• Participating in continuous improvement program and project or site objective as required.
• Support and execute transfer technology, new product, and extension market implementation.
• Maintain technical specification of material and component including creation, revision, or deletion.
• Proactively support Permanent Inspection Readiness ensuring all documentation is made available during inspections and Implement all corrective actions in a timely fashion following regulatory inspections and internal audits.

Preferred Education, Experience, And Skills

• Bachelor's degree preferably in chemical engineering or pharmaceutical technology.
• Minimum 1 year experience as process engineer or in manufacturing area or fresh graduate is also acceptable.
• Good communication skill both written and spoken English.