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Validation Engineer
Aussicht: 185
Update Tag: 13-11-2025
Kategorie: Qualitätssicherung / Qualitätskontrolle
Industrie: Outsourcing Offshoring Consulting
Position: Entry level
Jobtyp: Full-time
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Jobinhalt
Functieomschrijving Select Projects is looking for a Validation Engineer for a biopharmaceutical company in Geel.As Validation Engineer you will be responsible for the qualification of designated systems (both utility and process).The role of the validation engineer will be one of direct responsibility, on behalf of Sanofi, for the successful qualifications of defined systems. (incl. material certification, weld log/inspections, functional testing,.. where applicable).Reporting to the validation Lead or manager, the role of the Validation engineer will be as follows:Core Responsibilities- Write, review and approve validation & qualification protocols and reports, as well as execute protocols.
- Familiarize oneself with all elements of the process & utility design for assigned systems.
- Perform Qualification activities in a GMP biotech manufacturing facility
- Provide technical assistance to less experienced technicians/engineers.
- Review/approve Qualification documentation (e.g. vendor test documentation/commissioning documentation) for assigned systems
- Resolve protocol discrepancies and deviations.
- Generate, review and approve deviations
- Report & follow up on deviations, solving technical problems
- Participate in risk assessments
- Perform change control assessment
- Overseeing activities performed by third parties
- Engage with technical support functions (e.g. process, automation etc.) to resolve issues quickly as they arise through commissioning execution.
- Report on progress - frequency as per requested by validation Lead.
- At least least 3 years of experience in Qualification/validation
- Degree of Masters Qualification in Science or Engineering
- Knowledge of cGMP in a regulated
- Good knowledge of English and Dutch.
- Experience with the Kneat application
- Knowledge of (use) DeltaV / BMS
- Capability to work both independently and in a team environment
- Strong analytical and communication skills
- Strong interpersonal, organizational, and technical skills
- Possibility of a company car with fuel card
- Meal & eco vouchers
- Expense allowance
- Group & hospitalisation insurance
- 12 ADV-days on an annual base
- End-of-year bonus
- Single and double holiday pay
- Bonus system: collective bonus and individual bonus
- Possibility to participate in Flex Income Plan
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Frist: 28-12-2025
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