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6 дней назад

Senior CQV Engineer

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior/lead
Английский
b2
Страна
Netherlands/Belgium
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 CQV Engineer (Pharmaceutical Validation): Leading CQV and validation engineering for complex pharmaceutical and biopharma facilities, including process equipment, utilities, facilities, and supporting systems with an accent on GMP execution, validation strategy, and lifecycle documentation. Focus on coordinating large capital projects, managing validation deliverables and risks, and mentoring CQV engineers across the Benelux organization.

Location: Hybrid role based in Niel, Belgium, the Netherlands, Bornem, or Waterloo, Belgium; local travel may be required.

Company

hirify.global is an employee-owned international project delivery firm serving pharmaceutical, food, biotech, medical technology, and mission-critical sectors.

What you will do

  • Act as the validation engineering representative and technical subject matter expert on cross-functional facilities, utilities, and equipment teams.
  • Develop validation strategies and coordinate validation activities for small- to large-scale client projects.
  • Lead CQV for process equipment through basic design, detailed design, construction, and CQV phases.
  • Manage validation deliverables, schedules, budgets, project risks, and stakeholder communications.
  • Generate, review, approve, and lead validation lifecycle documentation, including validation plans, URS, qualification protocols, and reports.
  • Support risk assessments, change control, recruitment, department growth, and mentoring of junior engineers.

Requirements

  • Bachelor's degree in engineering or science; a professional engineering or science degree/master's qualification is preferred.
  • At least 10 years of CQV experience and completion of at least three major capital projects.
  • Experience leading CQV teams on large pharmaceutical projects, preferably in the biopharma sector.
  • Strong understanding of CQV execution methodologies, GMP pharmaceutical facilities, technical standards, and regulations.
  • Ability to scope work, prepare proposals and cost estimates, manage stakeholders, and communicate with senior management and clients.
  • Willingness to travel locally to meet project requirements.

Culture & Benefits

  • Employee-owned organization with an inclusive culture focused on mutual respect and belonging.
  • Corporate responsibility and sustainability are central to the business strategy.
  • Commitment to inclusion, diversity, and reasonable accommodations during the recruitment process.
  • Opportunity to help grow a CQV department within the Benelux organization.

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