Technische expertise in inspectieapparatuur en -technologieën (visuele inspectiemachines, leak testers, camera- en sensorsystemen, reject handling, automatisering).
Opstellen en documenteren van technische specificaties (EDS, P&ID’s, elektrische schema’s) en afstemmen met SME’s.
Werken volgens engineeringstandaarden en afstemmen met de Lead Engineer tijdens ontwerp, constructie en implementatie.
Opvolgen van constructie, installatie en inbedrijfstelling om te garanderen dat de installatie voldoet aan de specificaties.
Toepassen van projectmanagementtools (planning, budget, risico’s, rapportering, stakeholderbeheer).
Aansturen en opvolgen van contractors voor bouw, installatie en testen van de inspectieapparatuur.
Verantwoordelijk voor overdracht naar operations, inclusief volledige projectdocumentatie en projectafsluiting.
Opvolgen van opstartresultaten om te verzekeren dat de projectdoelstellingen behaald zijn.
Documenteren van constructie, verificatie en validatie in het engineering projectdossier.
Definiëren en uitvoeren van engineeringtesten, verificatie en validatie van inspectieapparatuur.
Opstellen van validatieaanpak, testprotocollen, verificatie- en validatiedocumenten.
Uitvoeren van testen en coördineren van goedkeuringen door SME’s en systeemverantwoordelijken.
Beheren en documenteren van afwijkingen en acties (CAPA’s, risicoanalyses, cGMP-review, document updates).
Profiel
Master/Bachelor in engineering of gelijkwaardig door ervaring.
Ervaring met inspectieapparatuur in farmaceutische productie is een pluspunt.
Kennis van testen, verificatie en validatie van systemen (ervaring in steriele omgeving is een plus).
Goede kennis van cGMP en compliancevereisten.
Communicatieve vaardigheden in Nederlands en Engels.
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]
Verantwoordelijk voor project engineering activiteiten rond fillingequipment (filling lines, isolators, e-beams, washers, tunnels en/of cappers).
Technische input leveren binnen projectteams, met focus op installatie, technologie of procesimplementatie.
Opstellen en reviewen van technische specificaties (EDS, P&ID’s, elektrische schema’s) samen met SME’s.
Toepassen van engineering standaarden en afstemmen met de lead engineer tijdens design, constructie en implementatie.
Opvolgen van constructie, installatie en functioneren van het equipment om conformiteit met de specificaties te garanderen.
Toepassen van project management best practices: planning, budgetcontrole, issue- en risicomanagement, rapportering en stakeholdermanagement.
Toezicht houden op externe contractors voor constructie, installatie of testing.
Verantwoordelijk voor overdracht naar operations, inclusief volledige projectdocumentatie en project close-out.
Opvolgen van start-up resultaten en garanderen dat de deliverables behaald zijn.
Correcte documentatie van constructie, verificatie en validatie in het projectdossier verzekeren.
Opstellen en uitvoeren van engineering tests, verificatie- en validatieprotocollen.
Coördineren van goedkeuringen met SME’s en system owners.
Anomalieën onderzoeken en oplossen (deviations, CAPA’s, risk assessments) en zorgen voor cGMP-conforme documentatie.
Profiel
Master of Bachelor in engineering of gelijkwaardig door ervaring.
Ervaring met fillingequipment of procesinstallaties in farmaceutische productie (steriele omgeving is een plus).
Ervaring met testing, verificatie en validatie van equipment.
Sterke technische en operationele kennis van installaties en compliancevereisten.
Ervaring met het opstellen van technische specificaties en projectdocumentatie.
Bekend met cGMP en kwaliteitsprocessen.
Ervaring met projectmanagement (planning, budget, stakeholders).
Hands-on mentaliteit en oog voor detail.
Sterke communicatieve vaardigheden in Nederlands en Engels.
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]
Scientist – Advanced Material Characterization and Investigations (AMCI) Contracting – Antwerp
Job Description As a Scientist, you will be part of the Advanced Material Characterization and Investigations (AMCI) group within the Analytical Development department. You will work in an international team of experts focused on advanced analytical characterization of pharmaceutical products and conducting analytical investigations within a global R&D context. You will join the Advanced Molecular Analysis (AMA) team, which specializes in structure elucidation using high-resolution mass spectrometry (HRMS), trace analysis, polymer characterization, and the analysis of complex molecules such as peptides and oligonucleotides. We are looking for a motivated chemist with experience in nitrosamine analysis. You will develop and implement innovative analytical methods, with a strong focus on chromatography and mass spectrometry.
Your Responsibilities
Develop and optimize analytical methods for the quantification of nitrosamines in pharmaceutical products, in compliance with applicable guidelines and quality standards
Perform in-depth root cause analyses with a focus on chemical reactivity
Collaborate closely with internal experts and multidisciplinary teams
Initiate and maintain collaborations with universities and research institutions
Ensure a safe working environment in accordance with EHS, GMP, and other regulatory requirements
Your Profile Education and Experience
PhD in analytical or organic chemistry, or a master’s degree with at least 6 years of relevant experience
Experience with nitrosamine determination is a strong asset
Solid expertise in mass spectrometry (Triple Quad, HRMS) is required
Familiarity with chromatographic method development is preferred
Knowledge of GMP and regulatory guidelines (ICH, EMA, FDA) is a plus
Fluent in English, both spoken and written
Personal Competencies
Eager to learn, scientifically curious, and able to work independently
Proactive and creative mindset
Strong collaboration skills in an international team environment
Result-oriented and detail-focused
Flexible, stress-resistant, and with a strong sense of responsibility
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical skills and soft skills. We are your career partner every step of the way. Are you interested in this position? Send an email to [email protected]. We warmly invite you to apply.
Ensure the safety and well-being of study subjects at assigned clinical sites.
Support the operational execution of clinical trials and ensure high-quality data collection.
Perform trial activities in compliance with SOPs, GCP, and applicable regulatory requirements.
Be accountable for site performance and delivery of high-quality data within project timelines.
Assist Clinical Operations staff and site personnel to resolve issues and implement CAPAs when needed.
Verify that Investigator Site Files are maintained according to regulations and company procedures.
Support patient recruitment and retention activities.
Conduct site visits to ensure compliance with protocol and regulations.
Contribute to the internal communication of important clinical data and events.
Support the organization of Investigator meetings and study trainings.
Serve as a reliable resource for up-to-date site status knowledge for stakeholders.
Assist in the implementation of new clinical systems and processes.
Collaborate with Investigators, IRBs/ECs, vendors, and internal staff.
Comply with all applicable laws, regulations, and company compliance policies.
Profile
Bachelor’s Master’s , PhD in Life Sciences, Physical Sciences, Nursing, or Biological Sciences required.
Fluency in English, French and Dutch.
Previous clinical research experience required.
Experience in medical device monitoring (or equivalent) required.
Solid understanding of regulations and standards in clinical research and medical devices/combination products.
Relevant industry certifications (e.g., CCRA, RAC, CDE) are an asset.
Clinical/medical background is a plus.
Proficiency in Microsoft Office (Excel, Word, PowerPoint).
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]
Als Cleaning Validation Specialist bent u verantwoordelijk voor het uitvoeren van periodieke reviews van cleaning processen binnen de drie productiedepartementen (Oral Solid Dosages; Liquids, Ointments & Creams; Sterile) om de gevalideerde status te waarborgen.
Verantwoordelijkheden
Coördineren en uitvoeren van jaarlijkse re-kwalificatiestudies binnen toegewezen IPT’s.
Ondersteuning bieden bij cleaning projecten (ontwikkeling & validatie) met o.a. partswashers, CIP en manuele reinigingsmethoden.
Coördineren van activiteiten samen met validatie, productie en laboratoria: afspraken maken, LIMS-aanvragen creëren, studies uitvoeren en resultaten evalueren.
Ondersteunen van het monitoringprogramma voor mogelijke kruiscontaminatie van actieve componenten.
Acute assistentie bieden bij sampling van dirty equipment of overschrijding van holding times.
Behandelen van afwijkingen (administratie, root cause analyse, opvolging).
Uitvoeren van change assessments of optreden als change owner.
Sluiten van audit gaps en opvolgen van observaties.
Kwalificaties
Bachelor Chemie/Biologie/Biomedische wetenschappen of gelijkwaardig door ervaring.
Of masteropleiding/apotheker/industrieel of bio-ingenieur (chemie, biologie, procestechnieken).
Relevante ervaring in farmaceutische processen, validatie en projectmanagement.
Vereiste Vaardigheden
Sterk in implementatie van theoretische technische kennis in de praktijk.
Uitstekende technische schrijfstijl.
Goede kennis van Engels (spreken, lezen en schrijven).
Voorkeursvaardigheden
Ervaring met validatieprocessen in de farmaceutische industrie.
Kennis van relevante regelgeving en richtlijnen.
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]
Product Quality als onafhankelijke kwaliteitsautoriteit voor productgerelateerde kwalificaties en validaties van toegewezen producten.
Zorgen voor compliant en “right first time” productlanceringen binnen Quality Operations (QO).
Borgen van Regulatory CMC-compliance van plantprocessen met de registratiedossiers.
Optreden als kwaliteitsautoriteit (cGMP-conform) voor:
Process qualification/validation
Method validation
Filter validation
Component qualification
Raw material evaluation
DHF
Uitvoeren van data verification en QA-review van:
Initiële marketing authorization filings en variaties
Antwoorden op vragen van Health Authorities
Briefing documents voor scientific advice meetings
Uitvoeren van compliance checks van registratiedossiers (verschillende markten) versus site practice.
Correcte en tijdige implementatie van goedgekeurde regulatorische wijzigingen op de site.
Opvolging van approvals en commitments per markt.
Profiel
Masterdiploma in een wetenschappelijke richting (bv. Farmacie, Biomedische Wetenschappen, Bio-ingenieur) of gelijkwaardig (PhD).
Minstens 2 jaar relevante ervaring in de farmaceutische sector en/of medical devices.
Ervaring of sterke interesse in Quality Assurance/Compliance en CMC voor (bio)farmaceutische producten.
Quality mindset en pragmatische aanpak.
Uitstekende analytische en probleemoplossende vaardigheden.
Sterke mondelinge en schriftelijke communicatieve en sociale vaardigheden.
Wetenschappelijke kennis en vaardigheden.
Talen: vloeiend Nederlands en Engels.
Uitstekende kennis van cGMP, regulatorische richtlijnen en relevante regelgeving voor medical devices en combinatieproducten.
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#26574
DSP QA Officer
Contracting – Brabant Wallon
Your responsibilities: Identical to USP QA Officer, but here we focused on Downstream processes such as purification, chromatography, UF, etc:
Review paper and electronic batch records line by line.
Validate data entries, timestamps, and operator actions.
Ensure deviations and alarms are properly documented.
Conduct field checks (logbooks, IT systems).
Collaborate with production and compliance teams.
Support training and coaching of operators on deviation initiation.
Your profile:
Minimum 5 years of experience, with strong production experience.
Experience in pharma is a must.
Experience in Downstream biomanufacturing.
Batch record and deviation review expertise.
Production background (Quality profile who has worked in production quality).
French fluency.
On-site availability.
Proactive and communicative personality.
Nice to have:
English proficiency.
QA experience in production.
Ability to coach operators.
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]
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]
Your responsibilities: Within the scope of you responsibilities you will ensure that the company products will be delivered to our Customers on time in efficient way and right quantities, following defined compliance standards and agreed procedures. In order to deliver you should be able to:
Manage ordering process and coordinate transport activities related to the commercial products including transport planning, shipping documentation and customs declaration.
Act as a unique point of contact for a high-quality customer experience for the company Markets and ultimately the patients
Build a strong relationship with local Supply Chain managers,
Be active and manage Markets queries by taking ownership/responsibility and liaising with the different internal departments, if necessary,
Be proactive in identifying their needs and potential problems to continuously improve collaboration and provide the best possible service.
Collaborate with applicable stakeholders internally and externally: planning, commercial, finance, QA, master data, transport carriers, warehouse operators…
Tasks and activities:
Follow up on low cover items and proactively co-ordinate with Planning to ensure timely delivery of products,
Act as intermediary between the company Markets and supplying sites,
Monitor daily open stock transfer orders for the company Markets
Analyze latest market/country information to understand mid and long-term supply requirements,
Create deliveries (upon shipping schedule in place) and daily follow-up on shipments,
Organization of transports and preparation of necessary documentation related to shipments, organized in accordance with the specific instructions of each customer, packaging site and inter-company customer including hazardous goods requirements when applicable.
Choose optimal mode of transport based on customer’s request and list of validated vendors,
Control transportation costs against agreed rate cards and spot quotations when required,
Co-operation with external/internal WHs for the control and monitoring of receiving, storage and order preparation operations, including the management of Idocs related to these activities.
Provide local Supply Chain managers with regular updates on their coming replenishments,
Address complaints to appropriate departments in charge and follow up if necessary,
Handle returns from the company Markets to supplying sites,
Execute contractual reconciliations or price transfers,
Issue Credit/Debit Notes where applicable,
Maintain client working instructions in Global Customer Service database & commercial client files in SAP for the company Markets,
Contribute in launch preparation for individual portfolios,
Participation in operational meetings within GL
Calculation and monitoring of KPIs followed during Tier meetings
Maintain proper and accurate Pre-Shipment and Post-shipment Administration
Management and follow-up of each customer's specific logistic instructions via customer file
Knowledge of relevant SOPs and supporting systems (eg. ColdStream, Trackwise, Qlik)
Lead the governance and monitoring of KPI’s across various aspects of our supply chain. This includes overseeing the performance of: Internal Warehouses,3PL Warehouses, Carriers.
Own and drive quality event, investigation, CAPA in our QMS.
Be part of various continuous improvement project.
Your profile:
2 years’ experience in Supply
Pharma experience is not mandatory, but familiarity with temperature-controlled logistics (e.g., food industry) is a plus.
Fluency in French & English
Strong sense of responsibility and autonomy.
Experience with SAP is a big asset.
Comfortable with logistics coordination and stakeholder communication.
Familiarity with GDP/GMP standards.
Prior use of tools like ColdStream, Trackwise, or Qlik.
Experience with KPI monitoring and continuous improvement projects.
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]
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]
