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7 дней назад

Asset Engineer – Commissioning & Qualification (Pharmaceutical and Life Sciences)

Формат работы
onsite
Тип работы
fulltime
Английский
c1
Страна
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
Asset Engineer – Commissioning & Qualification (Pharmaceutical and Life Sciences): Coordinating equipment and utilities qualification in pharmaceutical and biotechnology projects with an accent on GMP compliance, qualification documentation, and testing activities. Focus on assessing deviations and changes, reviewing IQ/OQ/PQ records, managing quality issues, and supporting inspections and continuous improvement.

Location: Ghent, Belgium

Company

hirify.global is an independent technology consulting firm providing guidance and solutions across information systems, telecom, life sciences, and engineering.

What you will do

  • Coordinate equipment and utilities qualification activities within project timelines and applicable quality and regulatory requirements.
  • Manage technical qualification documentation, including URS, SRS, DQ, IQ, OQ, PQ, plans, reports, and executed test records.
  • Act as technical owner for assigned systems and provide technical support on qualification questions and issues.
  • Assess changes, modifications, deviations, investigations, and non-compliance issues for their impact on qualification activities.
  • Coordinate testing, resources, documentation review, and approval with Quality Assurance and multidisciplinary teams.
  • Maintain qualification lifecycle activities, manage corrective actions and quality issues, and contribute to inspections, training, and continuous improvement.

Requirements

  • Degree in Engineering, Life Sciences, Biotechnology, or a related technical field.
  • Experience in equipment qualification and commissioning within the pharmaceutical or biotechnology industry.
  • Fluent Dutch and English.
  • Good knowledge of GMP requirements and relevant regulatory guidelines.
  • Experience with qualification documentation and testing activities, including IQ, OQ, and PQ.
  • Knowledge of deviations, change control, investigations, corrective actions, and quality management processes.
  • Experience reviewing technical documentation and coordinating qualification activities across multidisciplinary teams.
  • Strong analytical, problem-solving, organisational, communication, and collaboration skills, with attention to detail and the ability to manage multiple priorities.

Nice to have

  • Familiarity with quality management systems and documentation tools such as TrackWise.

Culture & Benefits

  • Permanent employment with projects averaging more than 18 months and opportunities for functional and geographic mobility across more than 60 countries.
  • Structured project check-ins, manager support, and monthly access to HR.
  • Training modules and fully funded Microsoft certifications.
  • Health insurance, remote work options, meal vouchers, a time savings account, and a referral bonus.
  • Inclusive equal-opportunity workplace with an active CSR and carbon-reduction programme.

Hiring process

  • Brief virtual or phone call followed by an average of three interviews, adjusted to the required seniority.
  • A case study or technical assessment may be required depending on the position.

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