Job Location : BRAINE-L'ALLEUD

• Location: Braine-l'Alleud
• Job #25423

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]
 

• Location: Braine-l'Alleud
• Job #25388

Logistics Compliance Specialist

The person will ensure pharmaceutical products are transported from point A to point B under appropriate thermal and technical conditions.

Scope:

• May involve products in launch phases or lifecycle management. As products evolve, new routes, destinations, and regulations must be considered.
• A strong quality mindset is essential since the team is subject to internal and external GDP audits.
• New documentation requirements mean the candidate will need to perform quality management reviews.

The Responsibilities

• Product Shipping Qualification: participate in regular project meetings with global project teams.
• Ensure shipping aspects are appropriately covered in alignment with project goals.
• Quality Activities: prepare for inspections and audits (internal/external). Dedicate time to ensuring compliance with GDP requirements and inspection readiness.
• Team Support: attend regular meetings with the Quality team to provide updates and align priorities.

Knowledge and Skills Requirements

• At least 5 years of relevant experience in supply chain (preferable, but flexible).
• Experience in the pharmaceutical industry is a must.
• A blend of QA mindset and supply chain expertise: working knowledge of GMP/GDP regulations.
• Experience implementing procedural control frameworks.
• Familiarity with audit/inspection protocols.
• Understanding of supply chain fundamentals, from long-term demand planning to patient distribution, including tools, terminology, and techniques.
• Strong team spirit and ability to integrate into an existing team.
• Languages: Fluency in English is mandatory; French is a plus.

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]
 

• Location: Braine-l'Alleud
• Job #25387

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]

• Location: Braine-l'Alleud
• Job #25357

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. 

• Location: Braine-l'Alleud
• Job #25352

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.
 

• Location: Braine-l'Alleud
• Job #25276

Industrial Lead Analytical (ILA) Specialist

The scope of the position is global within the entire Transformational Programs & Infrastructure Department of our client’s company. The role is focused on supporting, from an operational and project execution standpoint, the Analytical Industrial Lead (ILA) of commercial products, from late phase development (for commercial readiness) to the end of the life cycle of products.

The Responsibilities

• Providing support and expertise to specific projects led by your team or stakeholders (e.g. implementation of a new regulations, coordination of stability studies to support a process change, support submission readiness for various geographies …).
• Implementing analytical life cycle plans or integrated analytical solutions through project management.
• Being responsible for one or more cross-products activities or business processes (in full or a part of it) within the remit of your department.
• Supporting ILAs for operational activities within the remit of the department.
• Connect with people to develop and maintain interfaces with operations (e.g. QC laboratories, CMO, CLO).
• Use your project management skills to implement decisions, plans, and solutions.
• Show-off your energy and dynamism to evolve in a complex matrix environment.
• Work in autonomy with a problem solving & pragmatic mindset.
• Work on several projects in parallel with agility and smooth communication to support members of the team.

Skills and Knowledge Requirements

• Master’s degree in analytical chemistry or biology
• Industrial experience in the analytical testing field of pharmaceutical products with some project management activities.
• Experience of contact with QCs Experience in Biological products is a plus.

• Proven project management skills including planning, monitoring, issue resolution, risk mitigation and reporting to team manager.
• Knowledge of QC laboratory work, LIMS knowledge is a plus.
• Support of operational activities such as sample shipment, request of QC data, support QC trouble shooting, support to deviations.
• Exposure to GMP, Regulatory Affairs and Quality applied to analytical.
• Fluent in English and French.
• Customer and results oriented.
• Ability to summarize challenges and issues to management.
• Knowledge of basic Microsoft tools (Teams, Excel, Powerpoint, …).
• Ability to review data and documentation with a scientific eye.
• Knowledge of pharmacopeias and Biological and Physchem methods is a plus.

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]
 

• Location: Braine-l'Alleud
• Job #25274

Compliance Utilities GMP

Walloon Brabant – contracting 

Your responsibilities?  

Management of Utilities Deviations:

• Handle utilities-related deviations, primarily focusing on fluid systems, with an emphasis on OOS/OIT deviations.
• Use Scoop Compliance tools to manage and track deviations, with a particular focus on utilities
• Manage deviations related to periodic controls and automation
• Write, analyze, and track investigations to ensure compliance with corrective actions.
• Propose and monitor improvement plans and Corrective and Preventive Actions (CAPA).

Support and Interdepartmental Collaboration:

• Collaborate with QC laboratories, fluid production managers, automaticians, and QA/instrumentation teams to ensure compliance and proper system functionality.
• Work closely with on-site teams, understanding the technical issues related to utilities and fluids, without necessarily being a technical expert.

Your profile?

• Scientific background (or equivalent acquired through professional experience)
• Knowledge of utilities processes in the pharmaceutical industry and the GMP regulations associated 
• Experience in managing deviation flows (QA, qualification, fluid management). In-depth technical knowledge of fluids is not necessary, but experience in this field is a plus.
• Ability to ask questions and take a step back when facing dysfunctions.
• Strong communication skills (French is essential, basic English is sufficient).
• A proactive person capable of working autonomously while being solution-oriented.

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]
 

• Location: braine l'alleud
• Job #25267

Vendor Quality Lead Drug Product
This position will provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for our client’s Products.

The Responsibilities

• Be the central QA point of contact for the organization for investigations / deviations / out of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, ILA, ALO, Business) to allow assessment.
• Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, Side impact) and track the vendor’s performance.
• Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
• Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
• If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) escalation meeting. Coordinate vendor quality related investigations.
• Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors.
• Work closely with Global QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.

The Skills and Knowledge Requirements

• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
• Must be able to act in most circumstances without direct supervision and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
• Possess good auditing capabilities and skills.
• Must have the ability to manage projects / activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
• Root cause and risk management/assessment skills

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. Please reach out to Aylin, [email protected]

• Location: Braine-l'Alleud
• Job #25266

Operations Quality Partner
Contracting – Walloon Brabant
Your responsibilities?

• Work closely with Internal Bio Clin Manufacturing Team to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
• Ensure quality review of master and executed batch records for drug substance supporting clinical trial studies
• Release of materials used in production of drug substance for clinical trials
• Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review /approval Tech Transfer).
• Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
• Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect development activities and products. – Support Change Control and perform the QA evaluation
• Provide quality support for qualification and validation activities related to Biotech Sciences activities

Your profile?

• QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is an asset.
• A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
• Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
• Understands practical applications of GMP, compliance principles and theories including risk management
• Good written/oral communication in English
• Ability to work autonomously for the assigned activities with limited supervision

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. Do you have any questions? You can contact Anaïs Malikian, [email protected] 

• Location: braine l'alleud
• Job #25248

SAP System Quality Support

This global position as SAP System Quality Support will provide secondment to the main SAP System Quality Partner to deliver major projects linked to SAP PE1, more specifically linked to the Quality and Batch Management Modules. The goal will be to link business needs and IT constraints, to deliver lean processes within the modules and ensure sustainability through E2E testing. The function will provide QA expertise supporting continuous improvement such as reworking, standardization and alignment of processes; but also writing of procedures, trainings and coaching of local key users.

The Responsibilities
The SAP System Quality Support for Quality and Batch Management function in alignment with and under the guidance of the main SAP System Quality Partner will:

• Link business needs and IT constraints in projects, to deliver lean processes within the modules.
• Provide expertise in the modules to improve as much as possible including revamping, standardization, and alignment of processes; writing of procedures, trainings and coaching of local key users who will train End Users.
• Support incidents investigation, correction, and related improvements to be done in the systems as part of Day-to-day routine activities with IT and business entities.
• Ensure requested development to IT are matching business requirements by testing in depth new functionalities in systems.
• Ensure to keep the tool sustainable in order to be also able to support deployment of system upgrades.
• Help developing a community around the SAP System Quality team, which can be split into two parts: Community across Key users linked to SAP Improvement Project but also community within the module’s QM and BM with related LKUs (local key users).

Skills and Knowledge Requirements

• Master’s degree required.
• Strong Knowledge of SAP system preferably in Quality Management; HPALM knowledge is an asset.
• Must be able to communicate (write/speak) fluently in English (communication with IT outsourced), French is an asset.
• Analytical mind-set with a capacity to see the bigger picture.
• Negotiation skills.
• Strong written and oral communication skills.
• Self-driven, results-oriented with a positive outlook and a clear focus on high quality
• Fast learner.
• The candidate will need to be able to strongly defend Quality and standardization of the processes within the modules by negotiating, analyzing the details while seeing the bigger picture and by ensuring business and IT satisfaction.

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. Do you have any questions? You can contact Aylin Ugurlu at [email protected]