Process Engineer

** The job application and CV should be written in English !

** Detailed Job advertisement in Organon career site (apply through here) :

https://jobs.organon.com/us/en/job/R524461/Process-Engineer

The Position

This position will 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, investigation of any atypical or deviation in the product, process or equipment, material, and component. Develop operational team by training as per requirement to support the technical operation activities.

Duties/ Responsibilities: Primary activities include, but are not limited to:

• Execute process validation, cleaning validation, and equipment qualification that impact to quality of product
• Involve in tooling/engineering trials, installation, commissioning, and validation activities
• 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.
• Proactively support Permanent Inspection Readiness ensuring all documentation is made
• available during regulatory inspections and SMEs are available during inspections and support QMS Chapter if assigned.
• Implement all corrective actions are implemented in a timely fashion following regulatory inspections and internal audits.
• Support Safety to improve safety culture and ensure safety policies and guidelines are followed.
• Support Safety Investigations and corrective action implementation as requested.
• Responsible to keep abreast site safety & quality requirement and specific compliance policy and standards at daily work.
• Demonstrate quality leadership behavior, promotes a quality culture, and proactively supports cGMP compliance.
• Promote the site SHE culture, including but not limited to, the interdependency safety culture.

Required Education, Experience, and Skills:

• Educational background preferably in chemical engineering or pharmaceutical technology, 
• Minimum 3 years experience in pharmaceutical company, 
• Proven experience problem solving and troubleshooting in pharmaceutical manufacturing and packaging related process/product
• Proficient 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.
• Passionate for continuous learning and capacity to drive change.
• Good knowledge of the key concepts, principles, methods, and tools related.

Detailed Job advertisement in Organon career site (apply through here) :

https://jobs.organon.com/us/en/job/R524461/Process-Engineer