Project Engineer Laboratory Operations II Locatie – Antwerpen
Functie Als Project Engineer ondersteun je het analytisch labo met technische expertise en focus je op troubleshooting, continue verbetering en optimalisatie van analysemethoden en laboapparatuur voor grondstoffen, IPC-stalen en semi-finished producten.
Verantwoordelijkheden Als Lab Operations Project Engineer ben je verantwoordelijk voor het bewaken van de naleving van validatiedossiers voor analysemethoden en compendiale vereisten binnen Quality Control. Je ondersteunt de implementatie van nieuwe testmethoden en procedures en coördineert projectactiviteiten van planning tot oplevering. Taken
Opstellen en reviewen van protocollen, testscripts en rapporten
Beheren en opvolgen van afwijkingen (deviaties) en uitvoeren van root cause analyses (o.a. DMAIC)
Beoordelen van validatie- en transferresultaten van analytische testen
Valideren van bestanden en systemen (zoals SoftMaxPro en Excel)
Controleren van compendiale testen en naleving van kwaliteitsvereisten
Ondersteunen van QC-analisten bij testuitvoering en technische troubleshooting
Initiëren van corrigerende en preventieve acties (CAPA) bij kwaliteitsissues
Meewerken aan dossiers voor registraties van nieuwe geneesmiddelen of vaccins
In deze rol combineer je analytische expertise, kwaliteitsbewaking en projectcoördinatie om betrouwbare testmethoden en efficiënte labo-operaties te garanderen.
Profiel
Masterdiploma, bij voorkeur in (bio-)ingenieurswetenschappen, industriële farmacie, biochemie of biotechnologie
Enkele jaren relevante ervaring, idealiter binnen een farmaceutische of productieomgeving
Ervaring in een GMP-omgeving is een sterke vereiste
Uitstekende kennis van het Nederlands en goede beheersing van het Engels, mondeling en schriftelijk
Sterke communicatie- en samenwerkingsvaardigheden
Goed georganiseerd, nauwkeurig en kwaliteitsgericht
Sterk analytisch vermogen en probleemoplossend ingesteld
Ervaring met technische documentatie en sterke schrijfvaardigheden
Teamspeler met goede sociale vaardigheden en focus op continue verbetering
Wat kan je verwachten? Je komt terecht in een internationale en innovatieve werkomgeving waar veiligheid, kwaliteit en samenwerking centraal staan. Je ontvangt een competitief loonpakket en uitgebreide extralegale voordelen, met volop kansen om je technische kennis verder te ontwikkelen en bij te dragen aan uitdagende projecten.
Functie Als Project Engineer ondersteun je het analytisch labo met technische expertise en focus je op troubleshooting, continue verbetering en optimalisatie van analysemethoden en laboapparatuur voor grondstoffen, IPC-stalen en semi-finished producten. Verantwoordelijkheden
Eerste aanspreekpunt voor technische problemen rond routine-analyses en labotoestellen
Ondersteunen van validatie, kalibratie, maintenance en method performance
Coördineren van wijzigingen aan methoden en toestellen, inclusief documentatie (protocols, rapporten, SOP’s, change controls)
Onderzoeken en opvolgen van afwijkingen, root cause analyses en CAPA’s
Uitvoeren van analytische testen en validatieactiviteiten volgens cGMP/Pfizer richtlijnen indien nodig
Eindverantwoordelijkheid over projecten, inclusief planning, budgetinschattingen en nazorg
Aansturen van analisten binnen projecten en bewaken van kwaliteit en betrouwbaarheid van resultaten
Samenwerken met interne en externe stakeholders, rapporteren over voortgang en tijdig escaleren van risico’s
Verbeteren van productiviteit en ondersteunen van efficiënte implementaties
Profiel
Master in chemie, farmacie, bio-engineering of gelijkaardig
Min. 3 jaar ervaring in analytische chemie, troubleshooting of methode-/equipmentvalidatie (groeipad mogelijk)
Ervaring in GMP-omgeving
Sterke kennis van analytische technieken en statistische evaluatie
Kwaliteitsgericht, analytisch, georganiseerd en communicatief sterk
Sterk in technische documentatie
Vloeiend Nederlands en Engels
Goede kennis van MS Office
Wat kan je verwachten? Je komt terecht in een internationale en innovatieve werkomgeving waar veiligheid, kwaliteit en samenwerking centraal staan. Je ontvangt een competitief loonpakket en uitgebreide extralegale voordelen, met volop kansen om je technische kennis verder te ontwikkelen en bij te dragen aan uitdagende projecten.
Analyst Brabant Wallon – contracting Your responsibilities? The primary goal of the mission is to contribute to the release and stability testing of the company Biologicals as appropriate, according to the agreed quality standards and timelines. The scope of the mission is to support the pharmacopeia and immunoassays activities.
Major accountabilities: The main activities of this position will be:
Perform daily laboratory activities related to release and stability testing
Analyse results
Verify data (double check)
Work with other analysts in organizing the release and stability analyses of the laboratory
Follow up deviations, incidents and validate the results within a LIMS system.
Your profile?
Bachelor degree (or master’s degree), in biochemistry or in analytical chemistry
At least 5 years of equivalent experience in the biotech industry
Laboratory skills or quality skills
A good experience and expertise in at least the following analytical techniques:
pharmacopeia and immunoassays (ELISA, qPCR) applied to proteins.
A good knowledge of GMP standards in QC laboratory
Good interpersonal, verbal, and written communication skills with ability to balance
multiple priorities
Good knowledge of English (ability to read scientific documents)
Well organized, flexible, meticulous and rigorous, proactive, with a strong team spirit
Able to work in a multicultural 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.
Technical expert – Environmental Monitoring improvement & harmonization Brabant Wallon – contracting Your responsibilities? The primary purpose of this role is to lead the design, alignment, and implementation of a robust Environmental Monitoring (EM) framework, ensuring full compliance with current regulatory expectations while maintaining operational feasibility across multiple sites. 1. Technical Leadership
Lead the design and transformation of the Environmental Monitoring program across sites
Ensure alignment with current regulatory expectations, including : EU GMP Annex 1 (2022), Contamination Control Strategy (CCS) principles, FDA and relevant ISO standards
Define and challenge: Sampling strategies (viable and non-viable), Alert and action limits, Data trending methodologies, Investigation approaches for excursions and contamination events
Provide scientific and risk-based justification for all proposed changes
2. Process & Operating Model Definition
Co-develop the EM process and Target Operating Model (TOM) ensuring:
Clear roles and responsibilities (QA, QC Micro, Operations)
Effective governance and decision-making
Operational feasibility across sites
3. Multi-site Harmonization
Assess differences in EM practices across sites
Facilitate alignment and define harmonized standards
Balance standardization with necessary local adaptations
4. Deployment & Implementation
Lead the transition from current to target EM framework, including: Identification of what must be created, adapted, or maintained
Definition of a pragmatic deployment roadmap
Ensuring continuity of operations during implementation
Support adoption through: Training strategy, Stakeholder engagement, Change management actions
Your profile?
Minimum 5-10 years of experience in pharmaceutical microbiology / sterility assurance
Strong, hands-on experience with Environmental Monitoring programs in GMP environments
Good understanding of: EU GMP Annex 1 (2022); USP – Microbiological Control and Monitoring of Aseptic Processing Environments; 21 CFR Part 211 and FDA Aseptic Processing Guidance; ISO 14644 (cleanroom classification and control); Contamination Control Strategy (CCS) principles; Data integrity requirements (Annex 11, 21 CFR Part 11); Disinfection and microbiological control strategies (e.g. USP )
Project & Leadership Capabilities
Experience leading cross-functional projects or transformation initiatives
Strong facilitation and stakeholder management skills
Ability to translate regulatory requirements into practical, operational solutions
Scientific rigor with pragmatic mindset
Ability to challenge constructively and influence senior stakeholders
Strong decision-making capability based on risk and data
Ability to bridge QA, QC, and Operations
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.
Equipment Compliance Specialist Brabant Wallon – contracting Your responsibilities? The primary objective of this role is to provide analytical systems expertise to implement equipment supporting the management of physico-chemical method development activities from early clinical phases through to commercial stages. The main activities of this position will be:
Manage specific projects for the deployment of analytical equipment, including planning, execution, and follow-up, to ensure effective and timely implementation.
Collect user requirement specifications for new equipment, ensuring alignment with project objectives.
Prepare and maintain detailed documentation for each project, including URS, DV, IMA, and logbooks.
Coordinate with suppliers to manage equipment orders and ensure on-time delivery. Contribute to supplier qualification processes.
Plan and coordinate IT and qualification activities based on forecasted equipment usage.
Facilitate IQOQ activities conducted by vendors (Vendor IQOQ).
Ensure compliance of all project activities with GMP/GSP regulations, cybersecurity requirements, safety protocols, and internal procedures.
Provide support for system administration tasks, including the creation of new systems in ELN and review of VSL inventory compliance.
Manage and resolve issues that may arise during the equipment deployment process and during their transition into routine operation (e.g. contract reviews)
Your profile?
Master’s or bachelor’s degree in biochemistry or in analytical chemistry
At least 5 years of experience in the pharmaceutical industry
A good knowledge (and if relevant laboratory expertise) in at least one of the analytical techniques used in the laboratory: chromatography or electrophoresis capillary (CE, MAURICE,…) or spectrophotometry derived equipment (ICP, SoloVPE, Spectramax, FT-IR, …)
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules.
A good level of English is recommended for reports and oral communication.
Ability to handle multiple priorities and/or prioritization.
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.
Laboratory Analysis II (Analyst HPLC/UPLC) Location – Antwerp
Job content:
Perform a wide range of laboratory analyses within a pharmaceutical manufacturing environment.
Ensure accuracy and compliance with applicable standards, procedures, and work instructions.
Carry out routine and specialized tests (HPLC, UPLC, CGE, ELISA, particle analysis).
Work in accordance with Standard Operating Procedures (SOPs).
Support process development and root cause investigations according to established protocols.
Maintain the laboratory environment and ensure compliance with safety regulations.
Manage the maintenance and calibration of laboratory equipment required for process development.
Depending on the assignment, tasks may also include support with analytical method validation, management and processing of samples, inventory control of reagents and consumables, participation in improvement projects, and execution of administrative tasks.
Ensure that laboratory Key Performance Indicators (KPIs) are achieved.
Profile:
Bachelor’s or master’s degree in Life Sciences, or equivalent through experience.
Good command of Dutch and English.
Strong analytical skills, attention to detail, and a results-oriented mindset.
Ability to follow written and verbal instructions accurately, with strict adherence to safety procedures and GLP guidelines.
Proficiency in laboratory information management systems (LIMS), MS Office, and other relevant PC software.
Strong problem-solving skills, with the ability to investigate the root causes of issues and deviations and develop appropriate solutions.
Excellent interpersonal and communication skills for smooth collaboration with internal teams and external stakeholders.
Experience as a laboratory analyst in the biochemical or medical sector, or within Quality Control, is an advantage.
Experience with at least one of the following techniques is required: UPLC/HPLC (preferably on the Empower platform), capillary gel electrophoresis, or ELISA.
Flexibility in working hours is required; for senior profiles, experience in coaching junior colleagues and in method validation or instrument implementation is an asset.
What can you expect? You will join an international and innovative working environment where safety, quality, and collaboration are central. You will receive a competitive salary package and extensive fringe benefits, along with plenty of opportunities to further develop your technical knowledge and contribute to challenging projects.
Analytical Development Analyst Brabant Wallon – Contracting What are your responsibilities? This team’s primary responsibility is to develop, validate and transfer to internal and external partners, robust and efficient physico-chemical methods, according to the required regulatory requirement standards. The team also provides analytical support and expertise to process understanding and process validation of biological and chemical processes and is responsible for transferring methodology, technology, data and preparing regulatory submissions with business partners. Scope of the mission: The primary goal of the mission is to provide scientific expertise to contribute to contribute to manage physics-chemical method development activities from early clinical phases to commercial. The main techniques used are Liquid chromatography (Size-exclusion, Reverse-phase, affinity, Ion exchange, HILIC or HIC) or electrophoresis capillary (CzE). Major accountabilities: The main activities of this position will be:
Design experiments
Autonomously manage and perform daily laboratory activities related to method development, validation, transfers
Contribute to release and stability testing related to the project as appropriate.
Prepare and review/approve documentation (procedures, protocols, reports)
Analyze results.
Verify data.
Present/discuss results in project team meetings.
All these activities will be performed in compliance with the GMP/HSE rules and with the regulatory requirements for each development phase of the product. Who are you?
Master’s or bachelor’s degree in biochemistry or in analytical chemistry
At least 5 years of experience in the pharmaceutical industry
Strong and proven laboratory skills
Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix
A good practical experience and expertise in at least one of the analytical techniques used in the laboratory: chromatography (Size-exclusion, Reverse-phase, affinity, Ion exchange, HILIC or HIC) or electrophoresis capillary (CzE)
Expertise in analytical method development and validation
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules.
A good level of English is recommended for reports and oral communication.
Ability to handle multiple priorities and/or prioritization.
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.
What are your responsibilities? This team’s primary responsibility is to develop, validate and transfer to internal and external partners, robust and efficient physico-chemical methods, according to the required regulatory requirement standards. The team also provides analytical support and expertise to process understanding and process validation of biological and chemical processes and is responsible for transferring methodology, technology, data and preparing regulatory submissions with business partners.
Scope of the mission: The primary goal of the mission is to support the activities of the laboratory according to the agreed quality standards and timelines.
The main activities of this position will be:
Participate and ensure compliance with the lab housekeeping/5S program
Perform daily laboratory activities (reagents stocks, ordering, daily calibrations of instruments, preparation of mobile phases…).
Work with other analysts in sample management (receiving / shipment / aliquoting…)
All these activities will be performed in compliance with the GMP/HSE rules and with the regulatory requirements for each development phase of the product.
Who are you?
High School degree with scientific orientation
Previous laboratory skills in biotech industry is a plus
Knowledge of GMP standards in laboratory is plus
Good interpersonal, verbal, and written communication skills
Knowledge of English (ability to read scientific documents)
Well organized, flexible, meticulous and rigorous, proactive, with a strong team spirit
Able to work in a multicultural 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.
Bio DS Operations Quality Specialist Brabant Wallon – Contracting What are your responsibilities? The Bio DS Operations Quality Officer will oversee Upstream/Downstream/Media and Buffer quality assurance activities specifically related to manufacturing operations within new commercial biologicals drug substance facility. This role is crucial in ensuring compliance with internal standards. The position also involves driving continuous improvement in quality processes to uphold the highest standards of product quality and safety. Additionally, this role involves connecting to appropriate stakeholders to ensure the alignment with production. Quality Assurance:
Review and approve deviations, corrective and preventative actions, and change controls.
Review and approve Batch records.
Ensure escalation of quality problems to the appropriate levels of management following the standards set by the QMS.
Regulatory Compliance:
Participate in reviewing Annual Product Reviews.
Who are you?
Bachelor or Master’s Degree in science (Biotechnology, Chemistry, Pharmacist,…)
Minimum of 5 years’ experience in GMP Environment.
Demonstrated strong experience in biologicals drug substance operations (business and/or quality).
Demonstrate good communication skills with stakeholders.
Fluent in French and English.
Resistant to stress.
Ability to create support for training
Knowledge in other Biomanufacturing processes can be a advantage (validation, maintenance, metrology,…)
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.
