Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 62,000 staff across a network of more than 1000 independent companies in over 62 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2022, Eurofins generated total revenues of EUR € 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client' site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!

We are currently looking for a GMP Process Investigator (Scientific Documentation Specialist) within Manufacturing Excellence CAR-T EMEA. The MSAT CAR-T EMEA organization provides and supports a high degree of assurance that specific processes will consistently produce and meet predetermined specifications by deploying process validation, process system engineering, data architecture, continuous process verification, and process investigation.

Key Responsibilities:

The Process Investigator is responsible for providing quality investigation insights into the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes assessing process information, reviewing in-the-field manufacturing investigations, following up on various departmental post-implementation optimizations, and tracking quality metrics while ensuring a high-quality and compliant product supply. You will be:

• Collaborating with manufacturing teams to provide guidance and determine resolution for manufacturing issues/deviations.
• Ensuring accurate and timely reviews of manufacturing investigations, CAPAs, change controls and complaints.
• Demonstrating detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to cell-based product manufacturing or cell processing.
• Performing analysis on quality indicating data and identifying trends.
• Collaborating with functional departments to resolve issues.
• Contributing to cross-functional projects/teams with many stakeholders.
• Performing tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Providing guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
• Driving continuous quality improvements.

• A bachelor’s degree in molecular biology, cell biology, biochemistry, or related area in the Life Sciences is required. A master’s degree is a plus.
• Strong working knowledge of current Good Manufacturing Practices (cGMP).
• Experience working in a controlled, cleanroom environment under aseptic conditions is required.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Highly organized with the ability to pay attention to details and follow procedures.
• Fluent communication skills in English.
• Proficient in using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

• A full-time (40hours/week) Monday – Friday job.
• 80% working from home 20% working from the office.
• Job location: Beerse, easily reachable by public transportation from central station Antwerp (415/416/417).
• A Permanent contract with flexible working hours.
• Work in a fast-growing international organization.
• Meal Vouchers 8 Euro/Working Day.
• Eco-Cheques +/- 250 Euro/Year.
• DKV Hospitalization insurance.
• Additional 12 ADV days.
• A company well-being program targeting both mental and physical well-being.
• A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment.
• Personal development through learning on the job and additional trainings.