20 часов назад
Associate Engineer, Manufacturing – Downstream (Process) (Biotechnology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Engineer, Manufacturing – Downstream (Process) (Biotechnology): Supporting routine downstream biopharmaceutical manufacturing operations with an accent on process monitoring, GMP compliance, and process robustness. Focus on analyzing process trends, supporting deviations and CAPA, and contributing to NPI, startup, validation, and continuous improvement activities.
Location: Tuas, Singapore
Company
develops medicines and biopharmaceutical products, with a focus on improving health outcomes through science and manufacturing.
What you will do
- Support routine downstream biopharmaceutical manufacturing operations, including seed train, cell culture, bioreactor, chromatography, and viral inactivation activities.
- Monitor critical process parameters, process trends, and performance indicators to maintain defined control limits.
- Provide technical support to Manufacturing Operations and act as an operational process SME for assigned downstream unit operations.
- Support NPI, engineering runs, PPQ, process startup, validation, readiness, and operational handover activities.
- Participate in deviations, investigations, risk assessments, CAPA activities, and timely escalation of complex issues.
- Contribute to process improvements focused on robustness, yield, consistency, reliability, OE, and Lean manufacturing.
Requirements
- Diploma or Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related discipline.
- 3–4 years of experience in downstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated environment.
- Basic understanding of downstream biopharmaceutical processes and working knowledge of GMP and process data integrity principles.
- Basic data analysis and trending skills for process performance monitoring.
- Structured problem-solving, analytical thinking, technical writing, communication, and cross-functional collaboration skills.
Culture & Benefits
- Work in a regulated biopharmaceutical manufacturing environment with cross-functional collaboration across Manufacturing Operations, MSAT, and Automation.
- Support audit and inspection readiness through accurate and timely documentation.
- Participate in continuous learning and continuous improvement initiatives.
- Equal opportunity workplace committed to diversity, equity, and inclusion.
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