Your responsibilities: Commissioning and Qualification: Review IQOQ protocols and reports to ensure the qualification of CPP, support the team for risk analysis creation (SRA), review equivalence certificate, write validation plans…
Validation: According to the client’s standards and procedures, design the validation strategy through PQ protocol redaction, ensure the readiness for PQ validation, coordinate validation (on the floor job expected), manage unplanned events associated with validation, be the contact with QC.
Product validation: Understand the product validation lifecycle and ensure that the validation strategy is in line with the product validation strategy, support the product steward in product related topic (E&L, holding time, …).
Change Control: Assessment of the validation impact through eCC assessment (Stakeholder role expected), Coordinate eCC, and be responsible of eCC tasks.
Project management: Plan and manage PQ activities (material, documentation, people…), support the project planner, animation of meetings/workshops, help the production representative in the understanding of validation requirements.
Your profile:
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy).
At least 5 years’ professional experience in pharmaceutical environment, in quality and validation environment.
Good oral and written communication skills in French & English (for efficient communication with engineering office and suppliers).
Good Knowledge of GMP Regulated environment related to validation activities.
Good interpersonal relationship skills – To be a good team player to success in each validation.
Problem solving and achievement oriented.
Be organized.
Nice to have:
Knowledge of freezer dryers, filling lines and isolators would be an asset.
To maintain and keep up to date its knowledge and experience necessary to the function.
Ability to take decisions in stressful conditions.
Proactive and ready to take the lead to make things happen.
Ability to work under pressure on multiple deliverables within project timelines.
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. Are you interested in this job? I kindly invite you to apply or send me your CV, [email protected]
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]
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]
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]
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]
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]
Assurer la coordination de la validation de projets majeurs en Drug Substance et Product
Assurer l’approche ‘state of art’ de la Validations du plan de validation (= stratégie de validation) jusqu’au Validation Summary Report, incluant :
Ecriture, revue et approbation de document de validation tels que les Risk Assessments, les protocoles IQ/OQ/PQ, les rapports IQ/OQ/PQ …
Coordination de l’exécution des protocoles
Votre profil?
Expertise en validation IQ/OQ/PQ et GMP
Connaissance en validation de produit injectable.
Solides connaissances en organisation matricielle et en gestion de projet.
Solides compétences en communication, organisation et influence pour travailler de manière transversale.
Parler couramment le français et l’anglais
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.
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!
