Scientific Writer

Company Description

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, utilizing 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!

Job Description

Electronic Laboratory Notebook (ELN) Report Review

• Perform in-depth data review of the ELN reports generated by the CAR-T particulate matter analyst to ensure completeness, accuracy and alignment with internal AMCI standards.
• Provide feedback and guidance to the CAR-T particulate matter analyst to ensure robust and compliant good documentation practices (GDP).
• Approve the final ELN reports from the CAR-T particulate matter analyst in accordance with internal AMCI quality guidelines.

Technical Writing and Documentation

• Translate complex technical data and analytical results into clear, structured and compliant documentation for CAR-T particulate matter investigations (Non-conformance, Corrective and Preventive Actions and Trends) suitable for internal and regulatory review.
• Draft, review and finalize high-quality technical documents, including results summaries and scientific assessments for CAR-T particulate matter investigations (NC, CAPA and trends).

Cross-site Communication and Coordination

• Serve as the primary liaison between the Ghent and Beerse client sites, coordinating particulate matter analysis and ensuring efficient communication flow and knowledge transfer regarding CAR-T particulate matter investigations (NC, CAPA and trends).
• Act as the Sing Point of Contact (SPOC) for inquiries related to CAR-T particulate matter investigations (NC, CAPA and trends).
• Maintain and update Excel-based trackers to monitor analytical progress, report readiness and investigation timelines.
• Maintain and update the offline CAR-T particulate matter library used for assessment of particulate matter observed during CAR-T manufacturing process.
• Ensure accurate version control, file integrity and timely archiving of final reports and technical documents in according with documentation retention policies and regulatory requirements.

Out-of-Specification (OOS) Particle Task Force Participation

• Actively contribute to the OOS Particle Task Force by providing analytical data outcomes and updates and maintaining thorough particulate matter documentation.
•  Assist in evaluating trends related to particulate matter OOS investigations (NC, CAPA and trends).
• Collaborate with the AMCI and investigators team on continuous improvement initiatives aimed at optimizing the CAR-T particulate matter and classes and investigation (NC, CAPA and trends).
• Support the development and implementation of tools or templates to standardize and streamline CAR-T particulate matter analysis and investigations (NC, CAPA and trends).
• Ensure consistency, accuracy and scientific integrity across all written reports.
• Support data traceability and retrieval during cross-functional reviews or audits.
• Assist during audits and inspections by preparing documentation and providing clarifications.

Knowledge Sharing and Training

• Contribute to internal knowledge sharing through the creation of Standard Operating Procedures (SOP), Work Instructions (WI), templates and materials related to CAR-T particulate matter analysis and investigations (NC, CAPA and trends) or technical writing and documentation.
• Mentor and support colleagues in best practices related to CAR-T particulate matter analysis and investigations (NC, CAPA and trends) or technical writing and documentation.

Qualifications

• Bachelor’s or master’s degree in chemistry or a related scientific field.
• A minimum of 1 year experience working in an GMP enviroment is nice to have.
• Ability to work independently as well as part of a team in a fast-paced environment.
• Excellent attention to detail, problem-solving skills, and time management.
• Fluent English-speaking capabilities since this is the working language. 

Additional Information

• A full-time (40hours/week) Monday – Friday job. 
• A Permanent contract with flexible working hours. (Can start between 7am and 9:30am) 
• Home – Office: 80% - 20% 
• Place of work: Beerse, Belgium. Bus (x41) from antwerp stops in front of the facility. 
• Ocassionally work from Ghent 
• 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. 
• Access to Payflip- an innovative app that helps you take control and optimize your paycheck. 
• A platform to consult dermatologists for any skin-related concerns. 
• 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. 

What Happens Next
 
Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment center or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. 
 
Your data 
 
As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
 
Closing Date
 
We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.
 
Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful.