Process Engineer (Systems/Equipment) (Life Sciences)
Контакты
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
Singapore
gmpbiotechnologyvalidationprocess equipmentqualificationcleaning validationsingle use systemsquality risk management
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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На СНГ рынке: $1.4к/мес ($1.2к - $2.1к)
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У роли понятный фокус на валидации и конкретные задачи по GMP, но консалтинговый формат может означать смену проектов и меньше непрерывности, чем в штатной команде компании.
?Консалтинговый формат
Чёткие задачи
Обучение внутри компании
Биотехнологии
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Process Engineer (Systems/Equipment) (Life Sciences): Supporting the qualification and validation of manufacturing systems and process equipment with an accent on cleaning validation, single-use system lifecycle qualification, and GMP documentation. Focus on executing DQ, IQ, OQ, and PQ activities, applying quality risk management tools, and resolving qualification discrepancies with cross-functional technical and quality teams.
Location: Singapore
Company
hirify.global is an independent technology consulting firm providing guidance and solutions across Information System & Digital, Telecom, Life Sciences, and Engineering, with more than 1,000 clients and 7,600 employees across over 60 countries.
What you will do
Support qualification and validation activities for manufacturing systems and process equipment.
Develop, execute, and finalize cleaning validation protocols and reports.
Execute the full qualification lifecycle for single-use system assemblies and materials, including DQ, IQ, OQ, and PQ.
Apply Quality Risk Management tools to identify, assess, and control risks.
Define qualification requirements and acceptance criteria with technical and quality teams.
Review results, investigate discrepancies, coordinate with cross-functional teams, and maintain GMP-compliant documentation.
Requirements
Diploma or Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, or a related discipline.
At least 4 years of experience in pharmaceutical or biotechnology manufacturing systems, process equipment qualification, or validation.
Proven experience developing, executing, and finalizing cleaning validation protocols and reports.
Hands-on experience with the full DQ, IQ, OQ, and PQ qualification lifecycle for single-use system assemblies and materials.
Hands-on experience applying and documenting Quality Risk Management tools for risk assessments.
Good understanding of GMP requirements and system and equipment qualification documentation.
Strong analytical, problem-solving, communication, and documentation skills.
Ability to work independently and collaborate with cross-functional technical and quality teams.
Fluent English, written and spoken.
Culture & Benefits
International community representing more than 110 nationalities.
Trust-focused environment with internal career progression opportunities.
Internal Academy with more than 250 training modules.
Regular internal events, including afterworks and team buildings.
Opportunities to lead social or environmental impact projects through the WeCare Together program.
Equal-opportunity and inclusive workplace.
Hiring process
Brief virtual or phone call.
Approximately three interviews, with the number varying by seniority.
Possible case study, technical assessment, role play, or problem-solving scenario depending on the position.
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