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12 дней назад

Senior Validation Engineer – Cleaning & Process Validation (Pharmaceutical Biotechnology)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Senior Validation Engineer – Cleaning & Process Validation (Pharmaceutical Biotechnology): Planning, executing, and documenting cleaning and process validation activities in pharmaceutical or biotechnology environments with an accent on GMP compliance, sampling plans, acceptance criteria, and validation reporting. Focus on investigating deviations, supporting root-cause analysis and CAPAs, assessing change impacts, and maintaining validated processes.

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

  • Plan and execute cleaning validation and process validation activities.
  • Prepare and review validation protocols, reports, and supporting documentation.
  • Define validation approaches, acceptance criteria, and sampling plans with technical and quality teams.
  • Coordinate validation execution, including sampling, testing, and documentation.
  • Review validation results, investigate deviations, support root-cause analysis and CAPAs, and assess change impacts on validated processes.
  • Provide technical guidance and ensure documentation complies with site procedures and GMP requirements.

Requirements

  • Diploma or Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related discipline.
  • At least 5 years of validation experience in pharmaceutical or biotechnology environments, including both cleaning validation and process validation.
  • Experience preparing, executing, and reviewing validation protocols and reports.
  • Knowledge of cleaning validation principles, including residue limits, sampling approaches, and acceptance criteria.
  • Understanding of process validation principles and maintenance of a validated state.
  • Experience supporting deviations, CAPAs, and change-control activities.
  • Ability to coordinate validation activities and provide technical guidance to cross-functional teams.
  • Strong analytical, problem-solving, communication, and documentation skills.
  • 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 contribute to sustainability and ESG projects through the WeCare Together program.

Hiring process

  • Brief virtual or phone call.
  • Typically three interviews, with the number varying according to seniority.
  • Depending on the role, a case study, technical assessment, role play, or problem-solving exercise.

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