Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Обязанности в GMP-квалификации описаны подробно, но формат консалтинговых проектов и отсутствие данных об оплате оставляют важные условия для уточнения.
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Проектная работаПонятные задачиДолгие проектыОбучение за счёт компании
Оценка от Hirify AI
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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