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15 часов назад

CQV Engineer (Passivation) (Pharmaceutical Water Systems)

Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
Australia
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
CQV Engineer (Passivation) (Pharmaceutical Water Systems): Commissioning, qualifying, and validating pharmaceutical facilities, utilities, equipment, and water systems in Melbourne, Australia with an accent on cGMP compliance, validation documentation, and passivation activities. Focus on executing DQ, FAT, SAT, IQ, OQ, PQ, and PV work, validating PW and WFI systems, and coordinating with clients, vendors, and cross-functional teams.

Location: Melbourne, Australia

What you will do

  • Commission, qualify, and validate facilities, utilities, equipment, and pharmaceutical water systems.
  • Develop, review, and execute CQV protocols, reports, validation deliverables, SOPs, and quality documentation.
  • Support equipment qualification and confirm that systems meet design and operational requirements.
  • Participate in risk assessments, design reviews, FAT, SAT, IQ, OQ, PQ, and PV activities.
  • Coordinate with clients, contractors, vendors, and cross-functional teams to deliver project objectives.

Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
  • At least 2 years of CQV experience in pharmaceutical, biotech, or other regulated environments.
  • Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation.
  • Knowledge of cGMP requirements, 21 CFR compliance, water system validation, sanitization, and lifecycle management.
  • Experience with clean utility systems, especially Purified Water (PW) and Water for Injection (WFI) systems.
  • Experience commissioning, pressure testing, flushing, passivating, and qualifying pharmaceutical water systems.

Culture & Benefits

  • Consulting role involving collaboration with clients, contractors, vendors, and cross-functional teams.
  • Work focused on regulated pharmaceutical and biotech project delivery.

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