Secondary Packaging Industrialization Expert

  • Location: Braine l'Alleud
  • Job #25884

Secondary Packaging Industrialization Expert
Contracting – Brabant Wallon
Your Responsibilities

  • Lead packaging projects from initial design through to industrialization and lifecycle management of secondary and tertiary packaging solutions.
  • Provide technical expertise to internal sites, affiliates, and CMOs to ensure process efficiency, quality, cost optimization, and alignment with environmental objectives.
  • Manage projects, including change control processes, team communication, stakeholder engagement, and reporting to management.
  • Ensure compliance with international standards, regulations, and internal guidelines related to secondary and tertiary packaging.
  • Act as a subject matter expert for troubleshooting and optimization of packaging components and processes.
  • Support cross-functional teams, including purchasing, marketing, and supply chain, on technical packaging matters.
  • Lead and coordinate tech transfers, validation, investigations, and business support for packaging-related activities at internal and external sites.
  • Supervise communication and collaboration with one or more packaging sites.
  • Contribute to team objectives, planning, documentation, and continuous process improvements.

Your Profile
·  Proven experience in secondary/tertiary packaging within a pharmaceutical GMP manufacturing environment.
·  Hands-on experience in pharmaceutical project management, including tech transfers, product launches, and adapting to new regulations.
·  Strong analytical and conceptual thinking skills with the ability to understand complex technical and business challenges.
·  Capable of managing multiple projects and priorities efficiently, from development through commercialization.
·  Autonomous and pragmatic, with a proactive, problem-solving mindset and the ability to drive initiatives forward independently.
·  Demonstrated ability to work effectively within cross-functional and multidisciplinary teams.
·  Fluent in English (written and spoken); French is a plus.
·  Excellent communication skills, both written and verbal.
·  Positive and collaborative attitude with a strong sense of ownership.
·  Experience with artwork management is an advantage.

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]

 

Development Analyst

  • Location: Braine l'Alleud
  • Job #25859

Development Analyst
Contracting – Brabant Wallon

Your Responsibilities

  • Design and conduct experiments.
  • Autonomously manage and execute daily laboratory activities related to method development, validation, and transfers.
  • Contribute to release and stability testing in relation to the project, as appropriate.
  • Prepare, review, and approve documentation (procedures, protocols, reports).
  • Analyze experimental results.
  • Verify data accuracy.
  • Present and discuss results in project team meetings.
  • Perform all activities in compliance with GMP/HSE rules and regulatory requirements for each development phase of the product.

Your Profile

  • Master’s or Bachelor’s degree in biochemistry or analytical chemistry.
  • Proven expertise, preferably in the biotech industry.
  • Strong, proven laboratory skills.
  • Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix.
  • Practical experience and expertise in at least one of the following analytical techniques:
    • Chromatography (Size-exclusion, Reverse-phase, Affinity, Ion exchange, HILIC, or HIC).
    • Electrophoresis (Capillary: CGE, CzE, iCE, or MauriCE).
  • Expertise in analytical method development and validation.
  • Ability to work autonomously in day-to-day tasks.
  • Ability to author and review comprehensive and accurate procedures, protocols, and reports.
  • A good knowledge of GLP/GMP rules is a plus.
  • Good English skills (both written and oral) are recommended for reports and communication.
  • Ability to manage multiple priorities and prioritize effectively.
  • Strong interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
  • Ability to work in a matrix and customer-oriented environment.

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]

 

Development Lab Quality Ops Partner

  • Location: Braine l'Alleud
  • Job #25738

Development Lab Quality Ops Partner

Contracting – Brabant Wallon

Your responsibilities:
Part of the Development Quality Pharma Operational team, you will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development for:

  • The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing
  • The GSP oversight (non- GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK) and the Monheim site (DE).

You will also:

  • Drive continuous quality improvement process, ensuring 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.
  • Provide support to build the end to end “issued copy process’ for DEV/DSC entities.
  • Act as Reconciler by checking the correct completion of the “issued Copy” process,
  • Coordinate the development local instructions, liaise with dev key stakeholders in order to maintain common practices with regards to “issued copy” within development entities” ensuring appropriate application of the “issue copy process.”
  • Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections )
  • Provide guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
  • Identify, mitigate and subsequently resolve compliance and quality issues that may affect the company development activities and products. These lessons learned, once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities.
  • Support QA activities for all Dev QA entities ( Lab, pilot plant,…..)
  • Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of the company development activities and ensure compliance with regulatory and corporate requirements.
  • Partner with QA and CMC Development/DCS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
  • Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization
  • Manage Quality meetings to maintain adequate level of compliance of the business activities.
  • Ensure data integrity and compliance with regulatory requirements and industry best practices
  • Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems (deviation close out / change management/ complaints/ quality improvement).
  • Ensure Development Quality Management System directly support Technical Operations and development partner goals and objectives
  • Lead the GMP refresher project for CSC and Lab entities

Your profile:

  • Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
  • Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
  • 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.
  • QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
  • Fluency in French and English
  • 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

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]
 

Procurement Specialist

  • Location: Braine l'Alleud
  • Job #25722

Procurement specialist
Contracting – Brabant Wallon

Your responsibilities:
Our client is looking for a Procurement Specialist, responsible for procurement operations at a biological production facility for raw materials. This role is crucial in ensuring a smooth supply chain transition from project phase to commercial production.

  • Manage procurement operations, ensuring timely ordering and delivery of materials.
  • Process purchase orders and monitor stock levels using SAP (MM module, client-side transactions).
  • Communicate with planning teams and suppliers to guarantee smooth supply chain operations.
  • Handle supplier negotiations related to delivery schedules and urgent needs.
  • Address quality investigations in coordination with suppliers and internal teams.
  • Serve as the main point of contact for operational procurement issues.
  • Ensure compliance with procurement processes and guidelines.

Your profile:

  • Bachelor’s degree in Sciences
  • Experience in procurement, supply chain management, or related fields.
  • Strong knowledge of SAP MM module (client-side transactions, order processing, stock management).
  • Excellent organizational and problem-solving skills.
  • Ability to work autonomously while being a strong team player.
  • Fluent in English and in French.
  • Strong communication skills to interact effectively with suppliers and internal stakeholders.
     

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]
 

Documentation Coordinator

  • Location: Braine l'Alleud
  • Job #25701

Documentation Coordinator

Contracting – Brabant Wallon

Your responsibilities:
Our client is looking for a Documentation & Training Coordinator for a major project aimed at modernizing the artwork management system. This role is crucial to ensure the update and finalization of associated documentation, as well as the coordination of training for users. The person hired will work closely with a dynamic project team.

  • Coordinate the update of documentation according to the new defined structure.
  • Support Subject Matter Experts (SMEs) to ensure the timely delivery of documents.
  • Monitor and manage the documentation schedule.
  • Plan and organize the user training program (300+ people).
  • Ensure adherence to the schedule and follow up with stakeholders in case of delays.
  • Coordinate the transition period between the old and new systems.
  • Ensure smooth communication with the various teams involved.

Your profile:

  • Bachelor's Degree in Sciences
  • Fluency in French and English, Dutch is a plus.
  • Experience in documentation coordination for large projects.
  • Excellent organizational skills and strong responsiveness.
  • Diplomacy and ability to bring stakeholders together.
  • Advanced proficiency in Excel and project management tools.
  • Project management experience (without being a Project Manager) is a plus.
  • Experience in the pharmaceutical or regulated industry is a plus but not required.

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]
 

Supply Chain Business Process Expert

  • Location: Braine l'Alleud
  • Job #25679

Supply Chain Business Process Expert

Contracting – Brabant Wallon

Your responsibilities:

  • Understanding the specific needs of over 35 countries we operate in, balancing between standardization and local adaptation.
  • Translating these market requirements into clear supply chain processes.
  • Managing projects, coordinating with internal teams and external stakeholders.
  • Managing distribution processes, designing solutions that meet business and IT needs.
  • Ensuring smooth communication between business teams and IT departments, especially for market-specific solutions.
  • Leading Request for Proposals (RFP) processes with external partners and writing user stories when necessary.
     

Your profile:

  • Master’s degree in Sciences
  • Minimum of 5 years of experience in Supply Chain, ideally with expertise in distribution networks, supply chain management, and customer service management.
  • Fluent in English and French
  • Experience in Supply Chain Planning or Logistics role within pharma or food industry.
  • Good understanding of lean principles and methodologies.
  • Project management skills.
  • Ideally, experience in the pharmaceutical or a similar regulated industry, but experience in other industries (e.g. cosmetics, FMCG) could be considered.

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]

 

Logistics Compliance Specialist

  • Location: Braine-L'alleud
  • Job #25492

Logistic Compliance Specialist

Brabant-Walloon – Contracting

Our partner is looking for a Logistic Compliance Specialist to join its team.
Your responsibilities?  

  • Ensure Shipping Qualification is in line with the companies sop‘s and applicable referentials & standards (i.e. GDP, USP 1079, …),
  • Animate Shipping Qualification project team and ensure shipping qualification deliverables are in line with the overall project milestones,
  • Document shipping qualifications and associated documentation,
  • Manage associated Change Controls.
  • Get shipping Operational Qualification Report approved,
  • Get shipping Performance Qualification Report approved ,
  • Manage the creation of new datalogger set-up and update associated documentation,
  • Ensure proper handling procedure is in place at supplier level,
  • Report shipping qualification achievements and planning follow-up to project Core Team.
  • Manage project change control(s), including impact analysis, submission to CC board and validation, follow-up in company eQMS…
  • Manage Operational Qualification study:
  • Write OQ protocol, manage review workflow, integrate comments, manage approval workflow,
  •  Coordinate the study with the companies CLO (manage shipment requests, quotation, test execution follow-up, …),
  • Write associated OQ report, manage review workflow, integrate comments, manage approval workflow,
  • Write PQ protocol, manage review workflow, integrate comments, manage approval workflow,
  • Coordinate PQ shipments with the supplier and internal stakeholders (including Global Logistics),
  • Write associated PQ report, manage review workflow, integrate comments, manage approval workflow
  • Manage datalogger set-up creation (SAP ref., Quality Agreement update, associated QA documentation update…),
  • Set-up appropriate handling procedure and update relevant QA associated documentation for Global Logistics operations,
  • Provide SME support and training to key stakeholders including supplier, Global Logistics Operations, Quality teams etc,

Your profile?

  • Fluent in English,
  • Working knowledge of GMP/GDP regulations,
  • Proficient with qualification exercises,
  • Understands basics of logistics operations,
  • Ability to manage the “grey zone”, balance multiple priorities,
  • Able to work within an international team environment and good team player.

 

CMC Quality Solutions Specialist

  • Location: Braine l'Alleud
  • Job #25437

CMC Quality Solutions Specialist
Brabant Wallon – Contracting

Your responsibilities?
As Quality Solutions Specialist you will provide support to a group of CMC Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development.

  • Product Change Control Committee preparation and change controls follow-up
  • Maintenance and lifecycle management of QA product flows
  • Audits and Inspection anticipation and readiness
  • Product metrics
  • Review of Annual Stability Plan
  • SOPs and other control documents writing, review and approval as needed
  • Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
  • Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
  • Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
  • Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
  • Product Quality Complaint Committee preparation and complaints oversight
  • Product recall and product escalation meeting preparation
  • Annual report (i.e., reporting of change controls to Health authorities…)
  • Yearly Biological Product Report

Your Profile?

  • Minimum of 3 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience in GMP in Quality, Manufacturing or Quality Control would be an asset
  • Fluent and confident use of English
  • Knowledge in several areas of the global pharmaceuticals industry, including the interpretation and practical application of applicable regulations.
  • Autonomy and adaptability
  • Skilled and experienced in operating across cultures and in a multi-cultural environment
  • Understanding of CMC 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]

HSE Compliance Officer

  • 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]
 

Logistics Compliance Specialist

  • 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]