Qualification & Validation Coordinator – Life Sciences

SmartRecruiters, Inc.; Brussel; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

ALTEN is seeking a Qualification and Validation Consultant to support projects in pharmaceutical production. You will coordinate and execute the validation cycle to meet timelines across Production, QA and Maintenance functions.

The candidate should have a degree in engineering with GMP validation experience and be fluent in English and French, with curiosity for process equipment and GMP documentation. This Belgian role offers diverse international project exposure.

Qualifikationen

• Experience in qualification and validation within a GMP environment.
• Knowledge of production processes in the pharmaceutical industry.
• Ability to work in English and French.
• Curious to learn about production equipment and manufacturing processes.
• Organized and meticulous in drafting GMP documentation.
• Communicative and able to interact with Production, Quality Assurance, Maintenance.

Aufgaben

• Represent the Validation department on various projects.
• Design and implement the best Validation strategy.
• Coordinate project planning with Production / QA / Maintenance.
• Participate in risk assessment through drafting a Risk Assessment.
• Draft Functional Specifications (FS) and Design Specifications (DS).
• Write protocols and coordinate tests (URS / FAT / SAT / IQ / OQ / PQ).
• Analyze results and draft reports.
• Develop training and coach operators; manage deviations and CAPAs.

Kenntnisse

GMP validation experience

Cross-functional collaboration

Documentation drafting

Ausbildung

Engineering degree

Master7s in Bioengineering

Industrial Pharmacy

Related fields

Jobbeschreibung

• Full-time
• Contract Type: Permanent

Company Description

ALTEN is a world leader in Engineering and Technology Consulting with almost 60 000 employees, 88% of whom are engineers.
Operating in more than 30 countries, the Group supports its customers' development strategy in the areas of engineering, innovation, R&D and technological information systems.

Why choose ALTEN?

• It is a great opportunity to take part in the greatest technological challenges
• Working in a collaborative work environment provides close support
• We are a real career booster in France and abroad

Job Description

As a Qualification and Validation Consultant, your expertise will support the projects of our partners whose activities are established in the production of medicines or health-related products.

You will play a central role in coordinating and executing the validation cycle with the aim of successfully completing projects within the given timelines.

• Represent the Validation department on various projects;
• Design and implement the best Validation strategy;
• Coordinate project planning with all stakeholders (Production / QA / Maintenance);
• Participate in risk assessment through the drafting of a "Risk Assessment";
• Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS);
• Write protocols, coordinate, and ensure the proper execution of tests (URS / FAT / SAT / IQ / OQ / PQ);
• Analyze and interpret results in order to draft the corresponding reports;
• Develop training sessions and coach operators in the field; Manage deviations related to validation runs and implement the associated CAPAs.

Qualifications

• A degree in Engineering, a Master’s in Bioengineering, Industrial Pharmacy, or related fields;
• Experience in qualification and validation within a GMP environment;
• Knowledge of production processes in the pharmaceutical industry;
• The ability to work in English as well as French.
• Curious to learn more about production equipment and/or manufacturing processes;
• Organized and meticulous in drafting your GMP documentation;
• Communicative and enjoy interacting with various departments such as Production / Quality Assurance / Maintenance.

Additional Information

Our approach to sustainable development and social responsibility is built on three fundamental pillars:

People
We celebrate the rich diversity of our employees, who represent over 100 nationalities. We are committed to fostering an inclusive environment where everyone can thrive and make a meaningful contribution. We encourage skill development and actively support our talent in their personal and professional growth.

Environment
Our mission is to minimize our environmental footprint while promoting sustainable growth. We are committed to achieving carbon neutrality by 2050, a goal that guides our operations and shapes our strategic initiatives.

Sustainable Innovation
At ALTEN, we see the challenges of sustainable development as opportunities to drive research and innovation. With 31% of our internal R&D dedicated to sustainable innovation, we are determined to turn these challenges into value-creating and progress-driven solutions.

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