14 дней назад
MES Expert (F/M/X) (PAS-X)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MES Expert (F/M/X) (PAS-X): Designing, migrating, and validating Master Batch Records and MES functionalities in regulated pharmaceutical and life sciences manufacturing with an accent on GxP compliance, requirements management, and computerized system validation. Focus on coordinating testing and implementation, harmonizing master data, and supporting change management and end-user training.
Location: Puurs-Sint-Amands, Belgium
Company
is an independent technology consulting firm delivering technology and life sciences solutions through projects for clients worldwide.
What you will do
- Design, review, migrate, and approve Master Batch Records and master recipes in PAS-X.
- Analyze manufacturing processes, map future-state workflows, and manage business and user requirements.
- Support project planning, stakeholder workshops, risk communication, and change control activities.
- Prepare and execute validation and user acceptance testing, document deviations, and verify implemented solutions.
- Create SOPs and work instructions, deliver training, and support deployment and hypercare.
Requirements
- At least 3 years of relevant experience in a medior-level role.
- Experience in pharmaceutical, biotechnology, or life sciences manufacturing.
- Experience implementing or migrating regulated computerized systems and conducting requirements or fit-gap assessments.
- Experience writing or reviewing SOPs and procedural documentation.
- Experience with MES, LIMS, QMS, SAP-based solutions, and other regulated GxP applications.
- English and Dutch required.
Nice to have
- Knowledge of data migration and master data concepts.
- Experience with Computer System Validation in a GxP-regulated environment.
Culture & Benefits
- Long-term projects with major accounts and support from internal Centers of Excellence.
- Structured project check-ins, manager support, and regular HR communication.
- Functional and geographic mobility across areas of expertise and more than 60 countries.
- Training modules and fully funded Microsoft certifications.
- Health insurance, remote work options, meal vouchers, a time savings account, and referral bonus.
Hiring process
- Brief virtual or phone call.
- Approximately three interviews, depending on seniority.
- Potential case study, technical assessment, role play, or problem-solving exercise.
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