Scientist, Injectable Drug Product Process Development
Walloon Brabant – Contracting
Major Responsibilities
Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.) ;
Capture and analyze critical manufacturing process data for process understanding and process characterization ;
Perform process risk assessments ;
Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products) ;
Define the investigational medicine product preparation process in clinical trials ;
Provide support to ensure timely manufacture of stability and clinical DP batches ;
Provide support to process performance qualification/validation Ensure products are manufactured in accordance with the client's quality system, cGMP and latest regulatory requirements ;
Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities ;
Provide support in investigations of deviations and complaints related to DP quality ;
Support knowledge transfer from late phase development to commercial for validated DP processes ;
Contribute to develop the ways of working in the department.
Profile
Bachelor's Degree ;
2–3 years of experience in manufacturing or production support ;
Knowledge of fill & finish processes (even indirect) ;
Ability to work independently after a few months ;
Scientific critical thinking ;
Clear and transparent communication ;
Motivation and energy ;
Fluent English (documents, meetings, interactions) ;
Scientist grade.
Nice to Have:
Experience with syringes or injectable liquids ;
Experience working with CMOs ;
Understanding of fill & finish steps and their impact on the product ;
Ability to translate needs into lab language/protocols ;
Experience writing scientific reports.
Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Develop and maintain automation documentation and software for all assets lifecycle ;
Attend to workshops to ensure alignment with the different companies and disciplines ;
Participate to the overall automation strategy ;
Follow ‘up Automation Integrator and Vendor Packages during development and execution ;
Put in place strong collaboration with manufacturing entities to deliver strong support and expertise ;
Verify Automation Integrators deliverables and anticipate any cost increase ;
Attend to FAT / SAT / commissioning / Validation ;
Ensure automation deliverables follow GMP and HSE regulations ;
Proactively report and manage risks ;
Review verification protocols ;
Be part for 24/7 guard support in hybrid model with Automation Integrators (L1/L2) ;
Organize operator training ;
Perform handover to operation and support team ;
Manage punch list related to its packages / buildings.
Profil
Master's Degree
5 years in Engineering projects in Process Automation
Proven involvement in significant engineering projects, including risk/mitigation management ;
Good level of French and English ;
Strong knowledge of AVEVA System Platform (SP), OMI and RM with hands-on experience in troubleshooting and production support ;
Strong knowledge of SSMS (SQL Server Management Studio) for troubleshooting, running queries to extract and analyze data for investigations ;
Basic knowledge of SSRS (SQL Server Reporting Services) applied to designing, maintaining and troubleshootings generation of reports for operational needs ;
Basic knowledge of Aler AMS application with experience in configuring and monitoring the system for production support ;
Strong knowledge in design, execution and C&V ;
Ability to translate and present expert concerns to facilitate decision ;
Ability to work in highly dynamic environment and to handle challenging situations ;
High communication skills (leadership, negotiation, change management, facilitation) ;
Able to reach team decision and high sense of responsibility ;
Ability to challenge and argument ;
Ready to travel a limited period of time ;
Nice to Have:
IT knowledge (network, PC management) ;
Ability to communicate with IT ;
Pharma experience ;
Awareness of quality/regulatory requirements.
Our Offer
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Management of end to end clinical distribution operational activities, including coordination of orders following QP release, shipment requests & prioritization, returns, destruction and study close-out activities.
Drive strong partnership with stakeholders (internal and external).
Drive the coordination & prioritization for shipment planning with CSC stakeholders.
Ensure close-out activities are performed in a timely manner.
Responsible to ensure timely follow-up on distribution activities with carriers.
Contribute to distribution processes improvement, in collaboration with internal and external stakeholders, supporting OE & process improvements initiatives.
Act as primary contact for internal distribution activities (or forecast), ensuring any reported issues and handled correctly and communicated to stakeholders in a timely manner.
Review and archiving of trial GMP/GDP related documentation.
Support in writing procedures, deviations, investigations, change controls and resolve issues related to distribution.
Ensure the appropriate execution of CPLO procedures and compliance with GMP's and GDP's.
Understand regulation and adhere to established procedures to ensure compliant distribution.
Responsible for invoice management of Clinical Trials transport invoices.
Profil
Bachelor's Degree
A minimum of 3 to 5 years of experience in logistics is required
Experience in the pharmaceutical sector.
Strong knowledge of GMP (Good Manufacturing Practice).
Experience in logistics, ideally with clinical trials.
Fluency in both English and French.
Dynamic, team-oriented mindset.
SAP (logistics module) knowledge is a plus.
Good IT skills, quality mindset, and analytical/structured approach.
Nice to Have:
Experience with clinical trial archiving processes.
Knowledge of Clinical Trial Supplies practices.
Cold chain expertise.
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]
Ondersteunen van de QA Engineering afdeling bij alle Qualification/Validation activiteiten gedurende de volledige levenscyclus van systemen en processen (concept, project, operationeel, retirefase).
Reviewen en goedkeuren van kwalificatie- en validatiedocumenten, SOP’s, user requirements, risicoanalyses, testplannen, test scripts, change controls, CAPA’s, etc., conform cGMP.
Actief deelnemen aan engineering teams en samenwerking met andere groepen bij introductie of upgrade van systemen en processen.
Adviseren en ondersteunen bij voorbereiding en uitvoering van kwalificatie-/validatieactiviteiten en bewaken van cGMP compliance.
Opvolgen en afhandelen van afwijkingen tijdens kwalificatie-/validatieactiviteiten.
Rapporteren van status (kwaliteit, compliance, planning) aan QA Qualification/Validation team.
Profiel
Ervaring in chemische of farmaceutische industrie op het vlak van qualification/validation.
Kennis van cGMP regelgeving en richtlijnen.
Vermogen om technische informatie te vertalen naar begrijpbare informatie voor alle niveaus.
In staat om urgentie, kritischheid en impact van beslissingen correct in te schatten.
Multitasken en werken aan meerdere projecten tegelijkertijd.
Zelfstandig werken én functioneren in cross-functionele teams.
Sterke communicatieve vaardigheden.
Vloeiend in Nederlands en Engels (mondeling en schriftelijk).
Kennis van systemen binnen pharma/chemical sector: Manufacturing, Lab, Building, Utility, IT, Automation.
Ervaring met probleemrapportering, change requests en document management systemen (bv. Trackwise, Comet, TruVault) en test tools zoals Kneat.
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]
Complexe problemen en situaties structureren en stap voor stap en transparant aanpakken.
Proactief communiceren en rapporteren naar stakeholders binnen engineering, productie, STS en externe partijen.
Samenwerken en aligneren met stakeholders tijdens meetings en op de werkvloer.
Flexibel aanpassen aan het takenpakket afhankelijk van de projectfase (documentatie, werfopvolging, machinetesten).
Zelfstandig werken met veel initiatief, assertiviteit en een kritische blik.
Profiel
Master diploma in een technische of wetenschappelijke richting (industrieel ingenieur, burgerlijk ingenieur, bio-ingenieur, …).
Affiniteit met de farmaceutische sector is een must.
Ervaring in een farmaceutische of GMP aseptische omgeving is een groot pluspunt.
Validatie-ervaring is een groot pluspunt.
Ervaring met projectcoördinatie of aannemersbeheer is een pluspunt.
Sterke communicatieve en organisatorische vaardigheden.
Analytisch, punctueel en proactief ingesteld.
Grote interesse in technische, technologische en procesmatige aspecten.
Flexibel en in staat om om te gaan met frequente veranderingen in project/omgeving.
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:Brabant Wallon, Région wallonne, Belgique
Job#26711
Microbial Colony Counting and AI Support
Contracting – Brabant Wallon
Your responsibilities: We are seeking a motivated and detail-oriented Contract Worker to support the evaluation and assessment of supplier solutions related to microbial colony counting. This role involves contributing to the testing phase, generating comprehensive reports, supporting the evaluation of AI algorithms, and performing image labeling tasks. The ideal candidate will be a quick learner, able to work collaboratively within a team, and demonstrate autonomy.
Assess and evaluate supplier solutions for microbial colony counting, ensuring accuracy and reliability.
Conduct testing phases and document findings in detailed reports.
Provide support in testing and evaluating AI algorithms for image analysis and related data.
Perform precise image labeling and annotation tasks to support AI-driven solutions.
Collaborate with team members across departments to share insights and ensure alignment of objectives.
Adapt quickly to new tools, technologies, and methodologies essential for the role.
Maintain a high level of autonomy while managing tasks and delivering results within deadlines.
Your profile:
Proficiency in French and English (both written and spoken).
Educational background in life sciences, microbiology, computer science, or a related field (or equivalent experience).
Familiarity with microbial colony counting processes and laboratory testing methods.
Basic understanding of AI algorithms and their applications in image analysis.
Experience with image labeling tools or software is a plus.
Excellent analytical and problem-solving skills.
Ability to work collaboratively within a team while demonstrating independence and initiative.
Adaptability to learn and apply new technologies and methodologies quickly.
Preferred Qualifications:
Previous experience in microbial research or AI-based image analysis projects.
Knowledge of supplier solution assessments or vendor management.
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, Région wallonne, Belgique
Job#26702
Technical Assistant & Project Manager
Contracting – Brabant Wallon
Your responsibilities:
Actively participate in technology transfer and upscaling projects at CMOs.
Represent the company in projects managed by CMOs.
Collaborate with internal teams (quality, technical, regulatory, manufacturing).
Review and approve validation protocols and reports.
Monitor timelines, activities, budgets, and ensure regulatory compliance.
Manage deviations, change control, and CPV (Continued Process Verification).
Provide technical support and critical insight on sterile operations (compounding & filling).
Your profile:
Experience in sterile pharmaceutical environments (syringe/vial filling).
Knowledge of technology transfers.
Project management skills.
Quality mindset (QA).
Fluency in French & English.
Ability to work with external partners (CMOs).
Autonomy, integrity, and influencing skills.
Nice to Have:
Experience in validation, deviation management, CPV.
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]
Data & Process Engineer Contracting – Antwerpen Verantwoordelijkheden
Ontwikkelen van geautomatiseerde scripts in Python, SQL, R, DAX en/of VBA voor dataverzameling, verwerking en analyse.
Opzetten en onderhouden van ETL-processen: datastromen beheren van bron tot analyse met filtering, formatting, compressie en veilige opslag.
Automatiseren van analyses en datacollectie via scheduler-gestuurde scripts (Python, Power Automate, AirFlow, Windows Task Scheduler).
Ontwikkelen van eenvoudige Power Apps ter ondersteuning van productie-, maintenance- of CI-processen.
Bouwen van Power Automate flows voor repetitieve handelingen (alerts, goedkeuringen, automatische updates).
Integreren van databronnen (PI System, SCADA, Oracle SQL, DBeaver, datalakes) in analyses en tools.
Bewaken van GxP-compliance en data-integriteit (ALCOA+), inclusief traceerbaarheid, versiebeheer en audit-trails.
Analyseren van trends in efficiëntie, verbruik, capaciteit, robuustheid en performantie van installaties.
Vergelijken van productiecycli en parameters over verschillende installaties en processen (CIP/SIP, batching, holding, filling).
Vertalen van inzichten naar visualisaties in Power BI, PI Vision en Excel (incl. interactieve filters en slicers).
Ondersteunen van CI-initiatieven en verbeterprojecten met objectieve data en trendanalyses.
Samenwerken met Operations, Support Engineers, CI-teams, Maintenance en Automation en vertalen van inzichten naar concrete acties.
Ondersteunen van root cause analyses (M1/M2) met datagedreven inzichten.
Opbouwen van proceskennis in Preparatie, Formulatie en Filling om datatrends correct te interpreteren.
Delen van expertise, coachen van collega’s en bijdragen aan standaardisatie van tools en analyses.
Profiel
Master in een technische richting (bio-ingenieur, ingenieur, computerwetenschappen, chemie) of gelijkwaardige ervaring.
Ervaring met programmeren/scripting in minstens één taal (Python, R, SQL, VBA).
Sterke analytische vaardigheden met focus op procesoptimalisatie.
Interesse in of ervaring met farmaceutische of voedingsproductieprocessen.
Zelfstandig, nauwkeurig en communicatief sterk.
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]
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]
Participate in functional meetings required to perform activities within scope.
Perform periodic reviews of cleaning processes in three production departments (Oral Solid Dosages; Liquids, Ointments & Creams; Sterile) to ensure validated state.
Coordinate and execute annual requalification studies (focus on 1 IPT, backup for another).
Support cleaning projects (development & validation) for Partswashers, Clean In Place (CIP), and Manual methods.
Coordinate activities with validation, production, and laboratories (appointments, LIMS requests, study execution, data evaluation).
Support monitoring programs for potential cross-contamination through surface sampling.
Provide urgent support for equipment cleaning issues (e.g., exceeding holding times).
Handle deviations (administration, root cause analysis, CAPA).
Perform change assessments or act as change owner.
Contribute to closing audit gaps and observations.
Profile
Bachelor in Chemistry, Biology, Biomedical Sciences or equivalent through experience.
Strong analytical skills with attention to detail.
Ability to work in a GMP-regulated environment.
Good communication and coordination skills across multiple departments.
Flexible to occasionally work in early/late shifts if 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]
