8 дней назад
Process Development Engineer (MSAT)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Process Development Engineer (MSAT) (Biotechnology): Supporting technology transfer, process qualification, new product introductions, and process performance monitoring for biologics manufacturing with an accent on single-use processing, connected processing, and real-time process analytical technologies. Focus on troubleshooting unit operations, developing control strategies, leading technical investigations, and improving tech transfer efficiency in a regulated cGMP environment.
Location: Singapore Manufacturing - Tuas
Company
develops biologic medicines and operates an advanced next-generation biologics manufacturing facility in Singapore.
What you will do
- Coordinate technology transfer, process qualification, process performance monitoring, and troubleshooting of manufacturing unit operations.
- Support new product introductions, lifecycle changes, make-a-batch exercises, and facility-fit assessments.
- Develop process feasibility assessments and control strategies for new equipment and technologies.
- Contribute to investigations, technical assessments, deviation reviews, and product-impact evaluations.
- Build and improve technology-transfer tools, templates, and lessons-learned practices.
- Collaborate with drug substance technology, NPI, QA, Supply Chain, and manufacturing teams.
Requirements
- Master’s degree, or a bachelor’s degree with 2 years of directly related experience, or an equivalent combination of education and experience.
- At least 4 years of relevant experience in commercial biotechnology or pharmaceutical manufacturing.
- At least 2 years of experience in regulated environments, including cGMP.
- Knowledge of cell culture and/or purification processes, including single-use technologies.
- Experience troubleshooting unit operations and resolving and documenting investigations supporting cGMP production.
- Strong scientific, engineering, problem-solving, communication, and regulatory knowledge.
Culture & Benefits
- Collaborative environment focused on advancing science and serving patients.
- Professional development opportunities and support for career growth.
- Medical checks required for the role are covered by the company.
- Inclusive workplace with reasonable accommodation available during hiring and employment.
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