Project Engineer Site Technical Services Contracting – Antwerp
Taken • Bieden van technische en projectmatige ondersteuning om een robuuste farmaceutische productie van Medical Devices en Combination Products (MDCP) te waarborgen. • Ondersteunen van product lifecycle activiteiten zoals productlanceringen, technische onderzoeken, change management en continue verbetering. • Uitvoeren en ondersteunen van technische onderzoeken en probleemoplossing binnen productieprocessen. • Beheren of ondersteunen van technische verbeter- en implementatieprojecten. • Ondersteunen van design- en proceswijzigingen en uitvoeren van bijhorende risicoanalyses. • Zorgen voor naleving van GMP-richtlijnen en interne kwaliteits- en regulatoire vereisten. • Ondersteunen bij het onderzoek van klantklachten en implementeren van corrigerende en preventieve acties (CAPA). • Samenwerken met Manufacturing Quality Assurance bij de behandeling van Non-Conformance Reports (NCR) en de kwalificatie van materialen en processen. • Leiden of ondersteunen van technische projecten inclusief planning, risicoanalyse en uitvoering. • Voorbereiden en onderhouden van technische documentatie zoals protocollen, rapporten en risicoanalyses. • Ondersteunen van productlanceringen, line extensions en marktuitbreidingsactiviteiten. • Coördineren met Operations, Engineering, QA en leveranciers om een tijdige uitvoering van activiteiten te garanderen. • Identificeren van technische risico’s en bijdragen aan continue verbeteringsinitiatieven. • Samenwerken met productie, R&D, Quality en Regulatory Affairs binnen product- en proces lifecycle management.
Profiel • Masterdiploma in Engineering (Mechanisch, Biomedisch, Chemisch, Manufacturing) of gelijkwaardig door ervaring. • Ervaring in farmaceutische of medische hulpmiddelenproductie of technische projectondersteuning is een pluspunt. • Goede kennis van GMP en kwaliteitssystemen. • Sterke analytische vaardigheden en probleemoplossend vermogen. • Goede projectmanagement- en organisatorische vaardigheden. • Sterke communicatieve vaardigheden en teamgerichte houding. • Nauwkeurig, kwaliteits- en veiligheidsgericht. • Vlotte kennis van het Engels, kennis van het Nederlands is een plus.
Nice to have • Kennis van 21 CFR Part 820, ISO 13485 en ISO 14971. • Ervaring met medical devices of combinatieproducten. • Ervaring met injection molding technologieën binnen de medische sector.
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27502
QA Systems Officer Utilities
Contracting – Brabant Wallon
Your responsibilities: General QA Role
Ensure compliance with all relevant regulatory requirements
Organize adequate quality oversight on GMP documentation and activities.
Promote leading and proactive management of deviations, corrective and preventative actions and change controls.
Actively participate to the quality governance in place within the organization.
Ensure appropriate quality indicators are monitored (both leading and lagging) and adhered to.
Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS.
Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections.
Promote strong communication within Quality teams and strive for reducing variability to aim for One Quality Voice.
Foster a culture of quality, compliance, and continuous improvement within the organization.
Beltech Utilities support
Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval.
Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements.
Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
QA follow-up of utilities/Beltech related projects and project management.
Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures
Back up fonction
The position can act as back-up for his direct colleagues or for his manager according to the Manager 's instructions and after appropriate training
Your profile:
Master's degree in a relevant field (e.g., Engineering, Science or a related discipline).
Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
Experience with Quality Management Systems and Auditing is an asset
Fluent in French, very good level in English is required
Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
Team player with good interpersonal relationships and communication skills
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]
Mission: The Launch Excellence Project Engineering service is responsible for managing validation activities related to the introduction of new products at the manufacturing site. The role ensures that all processes linked to product launch comply with regulatory requirements, internal quality standards, and GMP guidelines throughout the product lifecycle. The service also contributes to project coordination, risk management, and quality investigation activities required for successful product implementation. Key Responsibilities:
Validation Activities
Plan, execute, and document validation activities associated with new product introduction.
Validate processes related to: formulation, filling, shipping, packaging
Ensure validation documentation complies with GMP and regulatory standards.
Execute and document urgent quality investigations.
Analyze deviations, identify root causes, and implement corrective actions.
Ensure traceability and documentation of all investigations.
Conduct risk assessments for processes and systems.
Identify potential risks related to product implementation.
Define and implement risk mitigation strategies.
Support process changes and system updates related to new product introduction.
Collaborate with cross-functional teams to implement improvements.
Coordinate project activities related to product launch.
Plan timelines, deliverables, and project milestones.
Track progress and resolve issues.
Provide project status reporting to stakeholders.
Prepare technical and validation documentation.
Ensure documentation meets regulatory and internal quality requirements.
Maintain organized and auditable project records.
Profile:
Master’s degree in a scientific discipline
Fluency in Dutch & English
Validation processes and documentation
Risk assessment methodologies
Quality investigation and deviation analysis
Knowledge of Good Manufacturing Practices (GMP)
Project planning and coordination
Technical report writing
Work may require flexibility for shift work depending on project needs.
Collaboration with multiple departments (quality, manufacturing, engineering, regulatory).
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]
Writing, reviewing and approving of validation plans and validation summary reports
Reviewing and approving of design documentation (TCD, ERES, URS, DQ, …)
Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
Writing and reviewing of Periodic Review Reports (PR)
Reviewing and approving of CSV specific documentation (inventory, …)
Reviewing of CVS specific SOP’S and Templates
Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems.
Ensure QA activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerized systems.
Support team and management during internal and external audits
Your profile:
CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
Certification in computer system validation or equivalent is a plus.
Experience in a computer systems validation role
Experience with SAP, MS Office
Fluency in French & English
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]
Beheren van validatieactiviteiten voor de introductie van nieuwe producten op de productiesite.
Zorgen dat processen voldoen aan regelgeving en kwaliteitsnormen.
Ondersteunen en documenteren van validatie van belangrijke productieprocessen: formulatie, vullen, verpakking, transport en distributie.
Uitvoeren van kwaliteitsonderzoeken bij problemen, oorzaken identificeren en oplossingen voorstellen.
Uitvoeren van risicoanalyses voor processen en productlanceringen en mitigatiemaatregelen definiëren.
Ondersteunen van proces- en systeemveranderingen bij nieuwe productintroducties en bijwerken van procedures om compliance te waarborgen.
Coördineren van validatieprojecten door activiteiten te plannen, teams te coördineren, voortgang te volgen, problemen op te lossen en statusrapporten op te stellen.
Voorbereiden van technische en validatiedocumentatie conform GMP- en regelgevingseisen.
Dagelijkse activiteiten kunnen zijn:
Schrijven of beoordelen van validatieprotocollen en rapporten.
Deelnemen aan projectvergaderingen.
Uitvoeren van risicoanalyses.
Onderzoeken van kwaliteitsafwijkingen.
Coördineren met engineering-, kwaliteits- en productieteams.
Functieomschrijving Als Project Engineer binnen het projectteam van het microbiologisch laboratorium ben je verantwoordelijk voor de verificatie en implementatie van microbiologische testmethoden voor nieuwe producten. Je speelt een cruciale rol bij het waarborgen dat testmethoden voldoen aan de huidige wetgeving, cGMP-normen en interne kwaliteitsstandaarden. Kernverantwoordelijkheden
Voorbereiden en opstellen van verificatieprotocollen voor microbiologische testmethoden.
Plannen van verificatietests in samenwerking met het operations-team van het laboratorium.
Opvolgen van verificatiemonsters en tests om tijdige uitvoering te garanderen.
Documenteren van verificatieresultaten in rapporten.
Initiëren, beschrijven en opvolgen van afwijkingen die zich voordoen tijdens tests.
Zorgen dat testmethoden voldoen aan de huidige wetgeving, cGMP en interne kwaliteitsstandaarden.
Profiel Vereisten:
Masterdiploma in een wetenschappelijke richting (bijv. bio-ingenieurswetenschappen, biomedische wetenschappen, biochemie of gelijkwaardig).
Bij voorkeur ervaring in aseptische farmaceutische productie of een microbiologisch laboratorium; recent afgestudeerden zijn ook welkom.
Pragmatische aanpak met een sterke drang om oplossingen te vinden en resultaten te behalen.
Uitstekende communicatieve vaardigheden en het vermogen om collega’s op verschillende niveaus te motiveren en inspireren.
Sterke technische schrijfvaardigheden voor documentatie en rapportage.
Vloeiend in Nederlands en Engels.
Vermogen om werk efficiënt te organiseren in een omgeving met veranderende prioriteiten.
Analytische ingesteldheid en oog voor detail.
Wat wij bieden:
Werken in een dynamische, wetenschapsgedreven omgeving bij een toonaangevend farmaceutisch of life sciences-bedrijf.
Betrokkenheid bij innovatieve projecten in microbiologie en productontwikkeling.
Mogelijkheden voor professionele groei en carrièreontwikkeling.
The position can act as back-up for his direct colleagues after appropriate training
OPERATIONAL QA ROLE
Assure that intermediates and active pharmaceuticals products get produced and released in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
Follow up of product related: change control, failure investigation, deviations, CAPA and action plans, qualification of dedicated equipment (protocols and reports)
Review of batch record from intermediates to drug substance
Batch disposition of chemical intermediates (DS manufacturing)
Review of master batch records and specifications
CONTINUOUS IMPROVEMENT
Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations
Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the site.
Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects
Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BPM and related supporting services
Ensure general cGMP training of internal customers
Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements
Ensure communication of compliance status and issues to appropriate levels of the organization
Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BPM and related supporting services
Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections
Your profile:
Min 3 years experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health related field
Experience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry
Experience with Quality Management System
Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision
Excellent team player attitude with excellent interpersonal relationship and communication skills
Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
Fluent in French and English
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]
