A manufacturer of active pharmaceutical ingredients and specialty chemicals for a range of customers both in Thailand and internationally, we are seeking an experienced Senior Process / Validation Engineer who will be responsible for the following activities:
- Reporting directly to the Managing Director you will work alongside the Quality Manager, Production & Maintenance teams and other site process specialists.
- Monitoring and improving the production process; leading projects related to process modifications; qualifying and validating all changes and new projects related to the manufacturing processes, cleaning, utilities and facilities
- Ensuring that the qualified status of the production, process equipment, cleaning, utilities and facilities are maintained and are compliant witih site procedures and cGMP standards.
- Monitoring the production process: reporting on process KPIs, contributing to identifying process variances, providing process analysis for projects and troubleshooting activities as well as process deviations.
- Following site procedures and cGMP guidelines to lead validation and study activities related to the manufacturing processes,cleaning, utilities and facilities and providing associated reports.
- Defining improvements for the production process, cleaning, utilities and facilities and assessing their impact on product quality.
- Leading and implementing process improvement / modification activities. Following the site procedures to lead qualification activities related to equipment, facilities and utilities’ installation and providing associated reports.
- Sharing experiences with other international facilities and training employees on the process and qualification.
- Presenting process and qualification / validation reports during audits.
- Realizing and/or coordinating process studies for industrial projects (preliminary studies).
- Any nationality, 30 – 40 years old.
- Bachelors / Masters Degree in a Chemical Engineering discipline.
- Minimum of 8 years’ experience working in a Process / Validation Engineering role in an API or Pharmaceutical manufacturing facility.
- Knowledge of cGMP and FDA standards is essential.
- A good command of English is essential.
A highly competitive basic salary and relocation assistance is on offer together with additional benefits.