• Locatie: Braine-l'Alleud
• Vacature #24239

Senior validation engineer (PQ)

Brabant Wallon – contracting 

Our partner is looking for a Senior validation engineer to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

• Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
• Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
• Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
• Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities. Write and coordinate approval of change controls related to technical modifications.
• Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
• Establish and monitor validation KPIs.
• Review handover of equipment / systems from suppliers and or other project stakeholders.

Who are you ? 

• More than 5 years of experience with PQ phase having led and managed validation projects, including sterile manufacturing.
• Must have experience of working on projects; project management experience. We need someone who understands and knows what to do but not a PM expert.
• Knowledge of safety, GMP and environmental regulatory requirements.
• Expert in reviewing and writing technical reports.
• EN is a must have
• Ability to work with other persons – team spirit.
• Homeworking : authorized, but must remain flexible according to project needs.

What can you expect ?       

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. 

• Locatie: Braine-l'Alleud
• Vacature #24238

Project Manager Advanced

Brabant Wallon – contracting 

Our partner is looking for a Project Manager Advanced to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

The consultant will have 2 “caps”: Project Management & SME Expert, will be involved in the validation of the new IT system.

• Drive the integration plan of the Quality Systems and Processes, to ensure business continuity as well as compliance at any time
• Drive the plan to implement the identified solution at global level
• Assess any GxP Data Integrity risks related and ensure adequate mitigation plan are in place and followed-up on.
• Ensures project team maintains focus on quality and continuous delivery
• Drives the implementation of the integrated systems and processes encompassing the change management principles (ADKAR model, change management model, etc.)
• Utilizes team feedback and metrics (quality, delivery rate, etc.) to track progresses of the changes and identify critical areas (in terms of resources, risks, impact, etc.)
• Communicates with leaders across the organization on a regular basis to ensure transparency into delivery, risk, issues, etc.
• Author, Review, and/or approve as appropriate any SOP, Change Control, Deviations, Investigation, CAPAs associated to the aforementioned activities and Data Integrity topics
• Support audit/inspections as required

Who are you ? 

• Required language: English, other language not required.
• Experience required: Data integrity, CVS (Computer System validation)
• Experience in GxP Data Integrity in the pharmaceutical industry
• IT knowledge required: Trackvise, Veeva, QALM (not mandatory but a +) 
• Strong organizational skills, excellent time management, excellent communication skills, good teamwork and team player
• Homeworking: 40%

What can you expect ?       

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. 

• Locatie: Braine l'Alleud
• Vacature #24227

Powder Scientist
About our client
To strengthen our materials Science team, based in the Pharma Sciences Department in Braine, Belgium, our client is looking to fill the position of: Powder Scientist.

About your role
Would you say your scientific approach is passionate above all? As a Powder Scientist you like to work in an environment where you can:
· Participate to the development of new products and processes
· Give directions from early development up to lifecycle management, from particle design up to final product
· Work autonomous, well-organized and use your pro-active thinking skills
· Be self-reflective on the gathered data
· Use your creativity to develop new analytical methods or even develop new technology
· Drive team spirit and encourage collaboration

Your responsibilities:
· Being a leader in powder characterization by leveraging Materials Science to drive overall Product Development in order to obtain the right drug for every patient
· Guide the Product Development by connecting powder /particle insights with manufacturing technologies and overall product performance
· Combine particle knowledge with crystallization science to optimize expected powder properties
· Developing method and performing analyses on active ingredient, drug product and excipients in the field of powder characterization
· Independently planning, conducting and interpreting experiments to determine the bulk powder and particle properties of raw materials, intermediates and final dosage forms, by mastering a number of characterization tools: laser diffraction (wet and dry method) and microscopy (optical and SEM) for particle size and shape measurements; gas pycnometry and fine solid displacement methods for true and envelope density determinations; physisorption for surface area quantification and porosimetry; powder rheometry to assess powder flow stability and strain-rate dependency; shear cell testing to measure powder flow functions and wall friction with application to hopper design; surface energy and wettability analyses via contact angle measurements (sessile drop, Washburn and Wilhelmy plate methods), standardized and customized methods to evaluate bulk/tapped density, powder compressibility, permeability, mechanical strengths of tablets and/or agglomerates, electrostatic charging, segregation, sticking and caking propensity; dynamic vapor sorption to assess powder hygroscopicity; differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) to understand the powder thermal behaviour.
· Performing chemical imaging on drug product or intermediates
· Being the reference person in powder characterization and training colleagues
· Applying QbD principles, multivariate analyses, and being in support of PAT development
· Keeping track of literature and state of the art scientific practices, and implementing innovative solutions
· Communicating with stakeholders and external partners (universities, centres of expertise…)
· Writing reports and give internal and external presentations

Education, experience, and skills required:
· Master / PhD in chemistry, pharmaceutics, physics or engineering or equivalent experience, on powder characterization
· Fluent in English
· Ability to work at the interface
· Able to combine multiple tasks and work simultaneously on different projects
· Soft skills: entrepreneurship, motivated, enthusiastic, reliable, team player, good communication

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]

• Locatie: Braine-l'Alleud
• Vacature #24222

Artwork Operations Coordinator

Contracting – Braine l'Alleud

What are the responsibilities?
Follow up the review of the Change Proposals and impact assessment documentation covering
E2E Artwork & Labelling process :

• acknowledgement of change proposal reception
• preparation of the kick off meetings in the context of change proposals
• follow up the review of the change and impact assessment for Artwork
• communication to stakeholders and change leader based on endorsement of the change in the context of Artwork
• tracking of CP projects to ensure endorsement is done on time

Create and manage AW projects in artwork management system:

• creation & scheduling of artworks projects;
• performing AW Project Coordinator’s tasks as defined in AW management system;
• coordination and tracking of the artwork creation and approval; follow-up of all project tasks to deliver the approved artworks respecting cross-functionally agreed timelines and other project due dates; keep the dues dates in the system up to date;
• working in close collaboration with all involved internal and external stakeholders of the artwork projects.
• mockup GARF approval, create and manage MU projects in artwork management system;
• closing AW projects and GARF projects;
• tracking of AW projects to ensure that tasks are completed on time and are kept aligned with deliverable expectations.

Experience and Knowledge requirement

• Bachelor's degree or equivalent experience
• Excellent computer literacy;
• Experience in coordination and administrative tasks
• Good communications skills and team spirit
• Used to work in a multinational/multicultural environment
• Fluent in English (written and oral), French is an asset
• Experience from a Regulatory and/or Supply Chain environment is an asset.
• Service minded with very good written and verbal communication skills
• Problem solver
• Structured, detail minded and well organized
• Stress resistant, accepts to be challenged and to challenge others
• Open minded, flexible and team oriented; capable of doing the extra mile to reach targets.

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 me.
 

• Locatie: Braine-l'Alleud
• Vacature #24211

HSE Construction Support

Brabant Wallon – contracting 

Our partner is looking for a HSE Construction Support to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

The role of the HSE Construction Support on the Genesis project is to implement the HSE strategy on the construction site in line with the project HSE strategy defined by the HSE Manager. The HSE Construction Support reports to the HSE Construction Manager. 

• Carry out regular safety visits and site inspections (main part of the job) and write reports.
• Participate in and follow up on actions defined at recurring meetings (whiteboard meetings, level 0 meetings, CSS, etc.). 
• Participate in the investigation of accidents/near misses.
• Assist in measuring and monitoring KPIs
• Assist with documentation management (paper and digital on ACC / Sharepoint) 

Who are you ? 

• Fluent in French & English 
• Bachelor's in construction with a safety aspect, experience in site coordination (no pharma experience needed but would be a plus)
• Mid-level profile – construction diploma
• Proactive, assertive, organized, solutions-oriented

What can you expect ?       

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. 

• Locatie: Braine-l'Alleud
• Vacature #24210

SME E&I

Brabant Wallon – contracting 

Our partner is looking for a SME E&I to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

Act as the technical reference for contracts related to its area of expertise.

1. Expert in his/her field of expertise
2. Author of specifications, calculations and drawings relating to his field of expertise
3. SPOC for contractors selected to build the facility in his field 
4. Collaborate with the company package owner to manage the contract: planning, budget, quality of execution.

Who are you ? 

• Knowledge in electricity, high and low current. Experience in electricity in the pharma field (data, access control, …).
• Proven experience in CAPEX projects
• 5+ years of experience in engineering for industrial and/or pharmaceutical environments
• Experience in the biotech environment in the bio-pharmaceutical industry is preferred.
• Knowledge of safety, GMP, and environmental regulatory requirements.
• Experience in legal conformity and energization process (3 green lights), proven experience in qualification

• Soft skills:

• Senior profile, minimum 10 years of experience in the field.
• Proven experience in qualification; knowledge of Verification (ASTM E2500) is a plus
• Good communication, rigorous, fully capable of acting on own initiative

What can you expect ?       

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. 

• Locatie: Braine l'Alleud
• Vacature #24194

Labelling implementation & partner specialist

Brabant Wallon – contracting 

Our partner is looking for a Labelling implementation & partner specialist to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

Product launches, regulatory variations or technical updates requiring modification of printed components:

• Ensure correct impact analysis of any Regulatory and other change requests from partners and implementation in all company's systems and Supply Chain
• Manage and coordinate the implementation project in artwork management system and ensure the tracking and follow up of all project tasks to deliver within legal time and other project due dates.
• Perform Write-off determination process
• Create and extend Finished Good and Printed Components codes in Master Data Management (MDM) system and SAP.
• Launch and manage master data collaborative workflows to ensure on time implementation
• Update Bill of Material in line with legal requirements
• Issue Master Packaging Sheet to ensure that CMOs are in possession of the necessary information for packaging the Finished Goods
• Launch deactivation of Finished Goods in master data collaborative workflows
• Continuous Improvement Responsibilities: Assist in continuous improvement of the Partner related internal master data and artwork processes as well as in the business processes and collaboration with Partners.

Who are you ? 

• Bachelor's Degree

• Service minded with very good written and verbal communication skills
• Problem solver
• Structured, detail minded and well organized
• Stress resistant, accepts to be challenged and to challenge others
• Open minded, flexible and team oriented; capable of doing the extra mile to reach targets
• Fluent in English (written and oral), French is an asset  

What can you expect ?       

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. 

• Locatie: Braine-l'Alleud
• Vacature #24120

Supply Officer

Brabant wallon – Contracting 

Vos responsabilités ?  
L’équipe Supply assure les différents flux logistiques et supporte les activités de productions. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP du BioPilot. Ils contribuent à la gestion de la logistique (Commandes, réceptions, transferts entre magasins, vêtements de travail, approvisionnement de matières, élimination de déchets,…).

• Coordination de projet – implémentation de XFP
• Être le point de contact pour le projet d’implémentation de XFP
• Prendre le lead et suivre les actions bloquantes ou en attente pour l’implémentation de XFP
• Diriger ou soutenir l’implémentation de solution relatif à l’implémentation de XFP
• Former les équipes opérationnelles à l’utilisation de XFP
• Participer à l’écriture, la mise à jour des procédures impactées par l’implémentation de XFP
• Soutenir l'équipe opérationnelle pour la fabrication de DS après la mise en oeuvre de XFP

Votre profil ?

• Très bonne connaissance de SAP
• Bonne connaissance Excel, Word, Powerpoint
• Expérience dans le contact fournisseur

Notre offre ?
Nous vous offrons un contrat à durée indéterminée ainsi qu'un package salarial attractif. Vous profiterez également de l'opportunité de vous développer personnellement et professionnellement à travers des formations internes.