• Location: Braine l'Alleud
• Job #26748

Automation & SCADA Engineer – Aveva

Walloon Brabant – Contracting

Major Responsabilities

• 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]

• Location: Braine-l'Alleud
• Job #26675

Process equipment procurement manager

Contracting – Brabant Wallon

Your responsibilities:

• Perform procurement activities:

• Assist to Kick-off meetings, prepare and present sourcing approach.
• Lead/participate/coordinate Procurement Packages activities in collaboration with Project team.
• Handle full RFI / RFQ processes as appropriate as per Procurement Plan.
• Organize presentation of offers and perform commercial analysis of bids (Total Value of Ownership optimization, business cases comparison).
• In collaboration with the legal department, set up contractual agreements ensuring appropriate company protection (risk analysis – KPI setting).
• Negotiate terms & conditions with suppliers.
• Decide on vendor shortlist for negotiation, prepare and communicate award decision.
• Consider sustainability criteria to ensure that the products and services purchased have the lowest environmental (during their entire life cycle) and most positive social (child labor provision, occupational health and safety, regulatory compliance) impact.
• Communicate progress and prepare appropriate reports as needed by Project leads, Owner’s Rep, etc.

• Manage Contract Execution (if required by the project)
• Manage suppliers contractual and commercial relationship to meet main project drivers and secure project quality, the budget and the schedule by:

• Supporting the project team as soon as potential issues arise and entering proactively into discussions with key partners.

• Following up and negotiating changes of scope, including contract amendments.
• Reporting on a weekly basis procurement status to the Project Manager and Engineering Lead.
• Preparing and leading regular governance calls with the main suppliers.
• Approving contractual milestones payment release.
• Handling provisional acceptance and close out of accounts with suppliers.

• Ensure consistency and adequacy of documents such as Performance Bonds, Bank guarantees, Invoices, confidentiality agreements.
• Report packages status to the company Category Lead and to Project Management, as required, highlighting progress and areas of concern.
• Track savings versus set targets and complies with reporting guidelines.

• Comply with the company and project strategy, procedures, guidelines and software usage.

Your profile:

• Minimum 3 years required
• Experience in procurement and contract negotiation
• Proven success in CAPEX projects (up to €50M) – Process EQUIPMENT.
• Bachelor's degree minimum
• Strong communication and stakeholder management skills
• Ability to deploy standard processes and solve problems
• Comfortable in technical and industrial environments
• Fluent in both French and English
• Nice to Have : Experience in Pharma industry
   

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 #26561

Development Analyst

Contracting – Brabant Wallon

Your responsibilities:

• 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]

• Location: Braine l'Alleud
• Job #26527

Technical Assistant & Project Manager

Contracting – Brabant Wallon

Your responsibilities:

• 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]
 

• Location: Braine-l'Alleud
• Job #26442

External Operations Quality Partner 
Brabant Wallon – Contracting 
What are your responsibilities?

• Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).

• Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects

• Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..

• Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.

• Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).

• Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).

• Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.

• Provide support in the evaluation of Temperature excursions for IMP.

• Management of Quality Complaints of IMP.

• Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.

• Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)

• Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements

• Contribute the preparation of audits (internal/external, regulatory inspections)

• Lead internal audits / Self-Inspections

Who are you?

• 5 years’ experience in QA/compliance experience in pharmaceutical regulated environment

• Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)

• Strong experience in batch review.

• Quality mindset with a pragmatic and proactive approach.

• Fluent in English is a must and French is a nice to have.

• Experience working with CMOs and vendors.

• Familiarity with GMP and GDP standards.

• Experience with quality systems (deviation management, complaints, change control)

• Familiarity with clinical packaging environments (vs. commercial) is a plus

• Certified auditor status is a plus.

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! 

• 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 #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]