Qualification and Validation Engineer (M/F/X)

工作内容

At Univercells Technologies, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all!! This job is the perfect opportunity to contribute to our mission and be impactful.

Based in Nivelles (Belgium), reporting to the Qualification and Validation Manager.

MISSION

As Qualification and Validation Engineer, your role is to be key actor on Qualification and Validation projects. You’ll ensure Univercells Products are functional and fit for purpose, by defining product qualification/validation strategies, defining testing alongside withmanufacturing, development, and service teams. You also support deployment of qualification services for our customers.

RESPONSIBILITIES

- Support various validation topics as: equipment qualification, computerized system validation, process validation, single use equipment’s qualification and validation, technology transfer, …

- Set up strategies trough validation master plan and test plans;

- Take part in product development meetings as an expert for Qualification/Validation and participate in the planning sessions;

- Review or prepare protocol and reports with creative and risk-based mindset

- Take part in testing execution and ensure the right Qualification/Validation process is followed;

- Follow-up testing execution performed by subcontractors (quotation, protocols & reports definition, sample preparation & planning);

- Develop strategies for validation-related services;

- Participate in continuous improvement of Qualification and validation processes;

- Act as Subject Matter Expert (SME) regarding Qualification and validation topics.

QUALIFICATIONS

- Master degree in engineering, bio-engineering, science or pharma;

- 2-5 years relevant experience in a GMP or GMP-supplier environment as a Validation, Qualification specialist/engineer, Validation project manager or Test Engineer

- Excellent writing skills in English (minimum level is B2);

- Excellent writing skills in French (minimum level is B2);

- Good master of Microsoft office;

- Ability of working autonomously and rigorously;

- Ability to take initiatives and interact with colleagues of other services;

- Team-oriented and proactive; with good communication skills

- Creative and pragmatic

- “Keep it simple” mindset;

- Customer oriented.

OFFER

We offer a long-term contract, a competitive salary package (health insurance, company car, pension plan, meal vouchers…) and the possibility of evolution in an international, dynamic and fast-growing company.

Is it appealing to you? Are you a powerful thinker combined with an efficient doer? Apply now !