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9 дней назад

Process Engineer (Systems/Equipment) (Life Sciences)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
c1
Страна
Singapore
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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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