10 дней назад
Lead Engineer, MSAT - Purification
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Lead Engineer, MSAT - Purification (Biotechnology/Purification): Leading process support, monitoring, investigations, and technical documentation for purification manufacturing processes at a Singapore production facility with an accent on GMP operations, process consistency, and data integrity. Focus on troubleshooting process deviations, updating batch records, supporting APR/CPV reporting and BLA filings, and mentoring cross-functional teams.
Location: Tuas, Singapore; office-first with remote work allowed for 20% of the time, one day per week
Company
operates globally connected biotechnology manufacturing sites supporting the development and production of medicines.
What you will do
- Lead preparation, execution, monitoring, and post-campaign activities for purification and related manufacturing processes.
- Monitor process behavior, identify trends, and lead investigations into issues, deviations, and process excursions across departments and customers.
- Review and update purification batch records, provide technical input for manufacturing documentation, and develop operator training materials.
- Support GMP and commercial runs, technical investigations, deviation close-outs, troubleshooting, and technical report authoring.
- Prepare Annual Product Review and Continued Process Verification summaries and support customer BLA filings.
- Maintain process databases, monitor batch-to-batch consistency, support audits and inspections, and provide technical mentorship.
Requirements
- More than 5 years of experience in biotechnology process development, process support, research, or a related manufacturing environment.
- Graduate degree in chemical engineering, biochemical engineering, biochemistry, chemistry, biological science, or a related field.
- Prior experience in purification.
- Ability to work primarily from the Singapore office and support in-person manufacturing operations.
Culture & Benefits
- Agile career environment and dynamic working culture.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Performance-based compensation programs.
- Daily company bus service from an MRT location near home to the Tuas site.
- Fully paid medical insurance with the option to enroll family members at partially subsidized premiums.
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