Senior Process Engineer

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, environment monitoring, and equipment qualification 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.
• Responds to customer needs in a timely and efficient manner. Liaise, coordinate, and communicate with others to effectively meet business needs.
• 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.
• Support or supervise on troubleshoot/problem solving in manufacturing and packaging process as required.
• Support or assist activities in term of technical perspective for both IPT.
• Proactively support Permanent Inspection Readiness and support QMS program.
• Cultivate strong strategic interpersonal relations within and across function and other colleagues at other sites.

Required Education, Experience, and Skills:

• Bachelor’s degree preferably in chemical engineering or Pharmaceutical Technology (other scientific/engineering also accepted).
• Minimum 8 years’ experience at process engineer field in pharmaceutical company (manufacturing and packaging).
• Proven experience on problem solving related process/product.
• Fluent in both written and spoken English.
• Oral and written communication skills.
• Rapidly acquires proficiency in emerging technologies and adeptly disseminates knowledge.
• Good level of knowledge of cGMP and regulatory inspections.
• Results driven person who displaying high integrity and honesty.
• Has problem solving, decision-making, and teamwork skills.
• Ability to lead, motivate and train others.
• Passionate for continuous learning and capacity to drive change.
• Comprehensive knowledge of the key concepts, principles, methods, and tools related.