10 дней назад
CQV Engineer (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
CQV Engineer (Pharma): Delivering commissioning, qualification, and validation activities for utilities, manufacturing process equipment, and instruments across Capex projects with an accent on cGMP compliance, controlled documentation, and equipment testing. Focus on authoring DQ, FAT, SAT, OQ, and PQ protocols, investigating deviations, reviewing engineering drawings, and resolving scope and quality issues.
Location: Hybrid, based in the Netherlands or in Niel, Bornem, or Waterloo, Belgium
Company
is an employee-owned international project delivery firm serving pharmaceutical, food, biotech, medical technology, and mission-critical sectors.
What you will do
- Perform commissioning, qualification, and validation testing for utilities, manufacturing process equipment, and instruments.
- Author CQV plans, protocols, master plans, design qualification documents, commissioning records, and final reports.
- Create and maintain controlled project documentation, job plans, maintenance schedules, and preventive maintenance plans.
- Review equipment specifications, manuals, engineering drawings, spare-parts lists, and P&IDs.
- Investigate failures and deviations, support CAPAs, and recommend solutions for identified deficiencies.
- Work with clients and multidisciplinary project teams to deliver projects within schedule, cost, quality, and scope requirements.
Requirements
- At least 3 years of CQV experience and a clear understanding of pharmaceutical operations and cGMPs.
- Ability to apply commissioning and qualification principles and develop and execute DQ, FAT, SAT, OQ, and PQ documentation.
- Working knowledge of GMP, GCP, GLP, and GAMP, with an understanding of construction environments, industry standards, and safety requirements.
- Ability to read and interpret P&IDs, identify system boundaries, review drawings, and test equipment for intended use.
- Strong analytical, organizational, time-management, writing, and problem-solving skills, with attention to detail.
- Excellent command of English required; Dutch and/or French preferred.
Culture & Benefits
- Work on challenging projects for international client organizations.
- Collaborate in a multidisciplinary environment within an expanding international company.
- Employee-owned culture focused on inclusion, diversity, mutual respect, and belonging.
- Commitment to sustainability and corporate responsibility.
- Reasonable accommodations are available during the recruitment process for candidates with disabilities.
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