Key responsibilities
Manufacturing process
- Study and optimize existing production processes to improve product quality.
- Use process simulation and data analysis to define and improve process strategies.
- Perform risk assessments (FMEA, HACCP) and ensure compliance with cGMP / ISO9001.
- Prepare technical documentation and process qualification/validation reports for internal use and external audits (including USFDA).
Continuous improvement & qualification
- Ensure equipment, utilities and facilities consistently support required product quality.
- Manage equipment lifecycle qualification and process validation/technology transfer.
- Identify and implement continuous improvement and tech upgrades within regulatory requirements.
- Lead troubleshooting with production teams and drive sustainable corrective actions.
- Perform gap and risk assessments (ICH Q9) for new equipment/processes.
- Lead, train and coach staff on qualification and validation activities; present qualification/validation reports during audits.
Qualifications
- Bachelor's or Master's in Chemical Engineering (preferred) or Industrial Engineering with chemical process knowledge.
- Minimum 7 years process engineering experience in GMP or ISO9001 manufacturing.
- Strong knowledge of production equipment, chemical processes, qualification, validation and process monitoring (trending, statistical analysis).
- Strong problem-solving, critical thinking and project coordination skills.
- Good documentation, communication and presentation skills; attention to detail.
- Proficient in MS Office/Project, MiniTab, AutoCAD and DCS.
- Good command of English (spoken and written).
