Quality System Contractor Brabant Wallon – Contracting
What are your responsibilities?
Support and prepare for regulatory inspections and audits.
Lead or assist in Quality Council and Risk Management Committee activities.
Develop and maintain internal audit and self-inspection programs.
Structure and align local documentation with global standards.
Implement and lead local Quality System Reviews.
Promote quality culture and regulatory awareness among staff.
Act as a mentor/coach for quality and regulatory requirements.
Benchmark industry trends and support local/global quality initiatives.
Who are you?
Minimum 8–10 years of experience required in pharmaceutical quality systems.
Pharmaceutical industry experience.
Demonstrated experience in quality systems and compliance.
Experience in audits and inspections.
Ability to work autonomously and proactively.
Fluent in French and English.
Strong interpersonal skills; not afraid to reach out and follow up with colleagues.
Nice to have:
Experience with biological drug substance (business and/or quality).
Agility to handle unpredictable changes and a stressful environment.
Experience collaborating and influencing across departments.
Additional certifications in quality or regulatory affairs.
Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We invite you to apply!
Prepare samples, process data, write reports, and present results.
Collaborate with the team to share instruments and knowledge.
Your profile:
Experience in mass spectrometry (high-resolution LCMS).
Skills in analytical method development.
Autonomous work style and ability to manage own schedule.
Good English proficiency (for meetings and international interactions).
Understanding and respect for GMP rules.
Ability to interpret complex spectra, especially for polymers and biomolecules.
Nice to Have:
Experience with polymers and large molecules.
Knowledge of biomolecules (proteins, antibodies).
Experience in a GMP environment.
Willingness to collaborate and support teammates.
Familiarity with various mass spectrometry instruments.
Our offer ? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Scientist, Injectable Drug Product Process Development
Walloon Brabant – Contracting
Major Responsibilities
Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.) ;
Capture and analyze critical manufacturing process data for process understanding and process characterization ;
Perform process risk assessments ;
Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products) ;
Define the investigational medicine product preparation process in clinical trials ;
Provide support to ensure timely manufacture of stability and clinical DP batches ;
Provide support to process performance qualification/validation Ensure products are manufactured in accordance with the client's quality system, cGMP and latest regulatory requirements ;
Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities ;
Provide support in investigations of deviations and complaints related to DP quality ;
Support knowledge transfer from late phase development to commercial for validated DP processes ;
Contribute to develop the ways of working in the department.
Profile
Bachelor's Degree ;
2–3 years of experience in manufacturing or production support ;
Knowledge of fill & finish processes (even indirect) ;
Ability to work independently after a few months ;
Scientific critical thinking ;
Clear and transparent communication ;
Motivation and energy ;
Fluent English (documents, meetings, interactions) ;
Scientist grade.
Nice to Have:
Experience with syringes or injectable liquids ;
Experience working with CMOs ;
Understanding of fill & finish steps and their impact on the product ;
Ability to translate needs into lab language/protocols ;
Experience writing scientific reports.
Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Develop and maintain automation documentation and software for all assets lifecycle ;
Attend to workshops to ensure alignment with the different companies and disciplines ;
Participate to the overall automation strategy ;
Follow ‘up Automation Integrator and Vendor Packages during development and execution ;
Put in place strong collaboration with manufacturing entities to deliver strong support and expertise ;
Verify Automation Integrators deliverables and anticipate any cost increase ;
Attend to FAT / SAT / commissioning / Validation ;
Ensure automation deliverables follow GMP and HSE regulations ;
Proactively report and manage risks ;
Review verification protocols ;
Be part for 24/7 guard support in hybrid model with Automation Integrators (L1/L2) ;
Organize operator training ;
Perform handover to operation and support team ;
Manage punch list related to its packages / buildings.
Profil
Master's Degree
5 years in Engineering projects in Process Automation
Proven involvement in significant engineering projects, including risk/mitigation management ;
Good level of French and English ;
Strong knowledge of AVEVA System Platform (SP), OMI and RM with hands-on experience in troubleshooting and production support ;
Strong knowledge of SSMS (SQL Server Management Studio) for troubleshooting, running queries to extract and analyze data for investigations ;
Basic knowledge of SSRS (SQL Server Reporting Services) applied to designing, maintaining and troubleshootings generation of reports for operational needs ;
Basic knowledge of Aler AMS application with experience in configuring and monitoring the system for production support ;
Strong knowledge in design, execution and C&V ;
Ability to translate and present expert concerns to facilitate decision ;
Ability to work in highly dynamic environment and to handle challenging situations ;
High communication skills (leadership, negotiation, change management, facilitation) ;
Able to reach team decision and high sense of responsibility ;
Ability to challenge and argument ;
Ready to travel a limited period of time ;
Nice to Have:
IT knowledge (network, PC management) ;
Ability to communicate with IT ;
Pharma experience ;
Awareness of quality/regulatory requirements.
Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Laboratory work and writing of methods and protocols.
Use of analytical techniques: chromatography (size exclusion, reverse phase, affinity, ion exchange, HILIC, HIC), capillary electrophoresis (CGE, CzE, iCE, MauriCE).
Collaboration with the team for theoretical and practical training.
Communication with the company contact point, planning, and technical experts.
Development, validation, and transfer of methods.
Design of experiments.
Autonomous management of laboratory activities related to method development, validation, and transfer.
Contribution to release and stability testing according to project needs.
Preparation, review, and approval of documentation (procedures, protocols, reports).
Analysis and verification of results.
Presentation and discussion of results in project team meetings.
Compliance with GMP/HSE rules and regulatory requirements according to product development phases.
Your profile:
3-5 years of experience in the pharmaceutical industry.
Good knowledge of protein chemistry.
Expertise in at least one analytical technique (chromatography or capillary electrophoresis).
Knowledge of Empower software.
Written and spoken French, written English.
Understanding of the principles behind the methods (not just execution).
Expertise in analytical method development and validation.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
Nice to Have:
Experience in biochemistry and separation of biological matrices.
Knowledge of separation techniques applied to proteins.
QC experience with understanding of methods.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Execute technology transfer and upscale projects, in close collaboration with the company cross-functional teams (MSAT, External Manufacturing, Industrial & Analytical Leads, Quality, Regulatory etc.) and CMO.
Depending on the type of project, act as project manager or project team member.
Review and approve all project documentation (protocols, reports, risk assessments, forms,…)
Regularly track the project’s progress (timing, activities, resources, costs) against the plan and adjust as needed
Collaborate with the Quality team to ensure product quality and consistency, and manage deviations and change controls
Ensure manufacturing processes comply with regulatory requirements and industry standards
Edit CPV reports for the company products manufactured at the CMO and tested by the company
Participate in projects (upscale, technology transfer): assist to internal and external meetings, review/approve project documentation, manage deviations and change controls, report project progress internally
Provide the technical expertise to support the company’s CMO to ensure effective processes
Implement project management best practices throughout the project
Your profile:
Master’s degree in engineering, Pharmaceutical Sciences, or a related field.
Minimum of 5 years of experience in pharmaceutical manufacturing processes.
Technical and industrial expertise in sterile pharmaceutical products.
Experience in managing technology transfers.
Experience with compliance in a GMP environment.
Experience in project management
Fluent in French & English (written and spoken)
Subject matter expert in technical / manufacturing aspects related to sterile DP compounding and filling activities
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
HSE Compliance Officer We are looking for a motivated and experienced individual to join our team in the local support department in Belgium, within the Health, Safety, and Environment (HSE) service. Although the role touches on health and safety, it focuses primarily on environmental aspects. The position involves working on environmental projects and maintaining regulatory compliance across multiple regions (Wallonia, Brussels, Flanders).
The person will be responsible for managing environmental issues, including the « Licence to Operate » for our sites in HQ, Leuven, and Braine, in relation to environmental and urban planning permits. The individual will closely collaborate with the engineering team to ensure the necessary permits are obtained.
The Responsibilities
– Environmental Permits Management (Licence to Operate): Preparation, modeling, and data collection for the environmental and urban planning permits required for site activities – Regulatory Compliance: Ensure compliance of installations with legal health, safety, and environmental requirements, especially regarding the risks associated with the storage of hazardous materials (CVZO). – Environmental Projects: Track and manage environmental projects, including internal audits, measurement campaigns, and reporting to authorities. – Environmental Management System: Maintain and improve our certified environmental management system. Participate in internal audits, measurement campaigns, and manage the administrative data related to environmental services. – External Collaboration: Work with external consultants and experts to ensure effective environmental management and smooth communication with local authorities.
Skills and Knowledge Requirements
– Scientific Background: Degree in a scientific field with a specialization or relevant experience in environmental management. – Environmental Management Experience: Experience in managing environmental issues, with good knowledge of local regulations (Wallonia, Brussels, Flanders). – Administrative Knowledge: Ability to understand and follow environmental regulatory requirements and perform necessary reporting. – Legislation Knowledge: Knowledge of environmental legislation in Belgium (Wallonia, Brussels, Flanders) is an asset. – Languages: English is not required, but knowledge of Dutch is a plus, particularly for the Leuven site. – ISO Certifications: Experience in an environment with a certified environmental management system (ISO 14001) is an asset but not a requirement. – Flexible Working Hours: This position is a 50% replacement for the sick expert, with flexible hours (Tuesday, Wednesday, and Thursday mornings). – Remote work is permitted when on-site presence is not required, but there are no fixed remote work days. Additional Assets: – Experience with Seveso risk management (hazardous materials storage). – GMP (Good Manufacturing Practices) certification is a plus, but not required. – Ability to ask questions and solve problems independently.
Our Offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
QC Equipment Specialist Join the QC team, working with a substantial analytical equipment park. The role goes beyond just qualification and maintenance of equipment, focusing primarily on the coordination of various activities related to these pieces of equipment. This role is akin to that of an architect, as it requires an overall view of the equipment's lifecycle.
The Responsibilities
Equipment Management:
In the event of a breakdown, identify and coordinate necessary actions with internal and external stakeholders.
Follow-up on equipment, install new equipment, and manage related projects.
Coordinate with support departments to ensure proper maintenance, qualification, and installation of equipment.
Project Management: Track timelines, budgets, and required resources for installation or upgrades of equipment.
Activity Coordination:
Serve as the point of contact for different stakeholders: qualification/validation, maintenance, IT, QA, laboratory (end users).
Perform testing, when necessary, in collaboration with the laboratory.
Ensure smooth execution of projects while adjusting priorities and juggling multiple tasks.
Planning and Monitoring
Manage several simultaneous projects, with up to 4 to 5 pieces of equipment to manage per person.
Use the Integrate software to track various projects and activities.
Required Skills and Profile
Rigorous and Organized: The candidate must be highly structured and able to manage shifting priorities.
Multitasking: Ability to work on multiple projects at once, sometimes dealing with urgent changes in priorities.
Experience with Laboratory Equipment: Knowledge of analytical equipment in GMP (Good Manufacturing Practices), such as HPLC, UPLC, UV, Infrared, PCR vessels, fridges, and freezers.
Familiarity with LIMS, Source, and Integrate systems is a plus.
Communication Skills: Ability to understand and write documentation in English (B2 level minimum), as equipment documentation is mostly in English. Ability to communicate with external suppliers and manage international interactions.
Our Offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Research Scientist Regulatory Bioanalysis Le consultant devra assurer la réalisation dans les meilleures conditions de qualité et de délai, le développement et la validation de processus bio-analytiques automatisés en environnement régulé GLP & GCP (BPL & BPC). Ces processus devront suivre et respecter les règles des Bonnes Pratiques de Laboratoire et les sections applicables des Bonnes Pratiques Cliniques. Ces processus auront pour but la quantification des analytes présents dans les échantillons biologiques provenant d’études précliniques et cliniques. La fonction s’appliquera aux points suivants : À la sélection, à l’implémentation et à la validation (computerized system validation for GLP and GCP activities) d’applications et d’instruments utiles au laboratoire de bioanalyses. Au développement de méthodes et de processus automatisés, utiles à la gestion et à la manipulation d’échantillons tests provenant de divers laboratoires, services ou départements, ou sous-traitants (études de pharmacocinétique, toxicologie, pharmacologie).
Les Responsabilités
Assurer de la bonne gestion du matériel et des équipements de laboratoire (maintenance, calibration, qualification), en tant qu’utilisateur, responsable d’appareil ou suppléant.
Développer des méthodes et des processus bio-analytiques automatisées.
Être responsable de la validation des applications et des instruments du laboratoire.
Réaliser les essais au laboratoire, et parfaire sa formation technique et scientifique.
Prévoir les besoins en produits, réactifs et matériel de laboratoire nécessaires à la réalisation des objectifs qui lui sont confiés.
Rédiger et revoir des procédures d’opération standards.
Assurer la conformité aux normes GLP & GCP.
Veiller au respect des procédures de travail et de sécurité.
Suivre l’évolution des connaissances dans les domaines techniques et scientifiques qui relèvent de la spécialisation du laboratoire et des objectifs qui lui sont confiés.
Connaissances et Expériences requises
Une connaissance pratique des normes GLP & GCP.
Développement de méthodes et de processus.
Rédaction et revue des procédures.
Notre Offre Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Analytical Scientist To strengthen our Analytical Sciences for our client, we are looking for an Analytical Scientist with a strong experience in analytical development, process support and at least hyphenated analytical techniques (Nuclear Magnetic Resonance – NMR). The position is based in our Characterization and Material Sciences department on their site in Braine l’Alleud, Belgium. In this role, you will contribute to the end-to-end analytical development of our small molecule and peptide portfolio, from preclinical through to the launch and the lifecycle of our marketed products.
The Responsibilities
Ensuring day to day NMR analysis.
Ensuring release and stability testing of API, standards, and clinical batches from Phase I to Phase III.
Ensuring release testing of raw materials, starting materials, degradation products and intermediate of synthesis.
Developing and validating fit-for-purpose of analytical methods according to aQbD principles (risk assessment, DoE, modelling) for APIs, Drug Products and In Process Control (IPC).
Transferring analytical methods to CDMOs, QC and manufacturing units and participating in their lifecycle management.
Providing high quality documentation of all technical work performed in the laboratory.
Actively participating to project meetings as well as internal scientific meetings.
Participating to the implementation of new state-of-the-art analytical methodologies and process improvements including bibliographic survey, technical scouting, and innovative methodological evaluation
Education Experience and Skills Required
This position requires a bachelor/master’s degree with at least 2 years’ experience (e.g. Analytical Chemistry) in the pharmaceutical industry is required.
Competence and autonomy in analytical development with NMR spectrometers.
Basic knowledge of NMR is highly recommended.
Key areas of expertise are the following:
Experience in NMR for characterization, quantification, and structural identification of compounds.
Experience in the development of analytical methods for small molecules and/or peptides.
Understanding of regulatory, GMP and safety environments
Experience using Bruker instruments and knowledge of Topspin/MestReNova is a plus.
Knowledge of organic chemistry to facilitate the interpretation of spectroscopy results is a plus.
Knowledge of the other characterization techniques (MS / IR / NIR / …)
Key skills are the following:
Able to work and respect the procedures in a regulated environment including good practices and HSE.
Good interpersonal, verbal, and written communication skills in French and/or English.
Team player, highly motivated with a strong client orientation.
Demonstrated motivation for laboratory work and hands-on experience with analytical instruments.
Ability to work in a matrix organization in different technical areas.
Be able to find autonomously technical solutions and activate all appropriate internal /external experts to solve the issue.
Be able to efficiently translate the data collected into knowledge that meets the needs of the project.
Must be able to manage scientific tasks independently to meet deadlines within given challenging timelines.
Our Offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
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