Objectives:
Developing, optimizing, and improving manufacturing processes to enhance productivity, quality and safety.
Ensuring compliance with safety, environmental and regulatory requirements in all process engineering activities.
Monitoring and analyzing process data, identifying trends and proposing solutions for process improvement continuously.
Collaborating with cross- functional teams to ensure smooth integration of new processes, technologies and equipment.
Identifying and implementing process improvements to reduce costs, minimize waste and increase efficiency.
Performing process capability studies, statistical analysis and data- driven decision- making to achieve operational excellence and meet production targets.
Main duties
SOP Adaptation & Issuance Capability:
Ability to convert R&D processes into feasible, clear, and repeatable production SOPs.
Good knowledge of GMP / ISO / ISO 22716.
Competent in adjusting: Raw material charging sequence, Mixing time, Agitation speed, Operating temperature
Able to collaborate with QA to officially issue and control SOPs.
Experience in drafting SOPs that are practical, unambiguous, and operator friendly.
Problem- Solving & Process Troubleshooting:
Optimize existing processes to reduce cost and improve quality.
Implement process control systems, monitor performance, and identify areas for improvement using data analysis – Incomplete dissolution/ Lumping/Phase separation/Incorrect viscosity/Poor Homogeneity
Maintain Process documentation – SOP’s, PFD’s and PID’s
Conduct risk assessments, ensure compliance with Health, safety and environment regulations, implement mitigation strategies
Cross- Functional Communication:
Able to communicate clearly, technically, and assertively.
Work with cross functional teams , R&D/Production/QA/QC, provide technical support and train staff on new processes and equipment,
Effective collaboration with: R&D – to understand formulation intent, Production – to work within equipment limitations, QA/QC – to ensure compliance.