Organize, manage and participate in QA activities from early-phase to commercial manufacturing of customer specific APIs, including:
Review and approval of the documentation linked to quality agreements, process and analytical optimization & validation, manufacturing operations and stability to comply with the cGMP or other legislation, with the internal Quality System and customer requirements
Management and approval of change controls, CAPAs & deviations, OOS and participation in on-line problem solving with other departments
Writing of Process validation master documentation and Product Quality Review
Release of API batches in close collaboration with QA shopfloor team
Work in a GMP and Quality environment
Recommend changes in practices to enhance the conformance to GMP within all departments
Perform internal and external audits as required
In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations.
Information/Communication:
Be the point of contact for customers quality topics (audits, customers requests, complaints and recalls)
Inform management in case of any major quality or people management problem
Make personnel aware of the importance of safety, environmental and GMP issues
Your profile?
Education in Sciences with minimum 3 years-experience in QA in a GMP Environment
Experiment in customer complaints management
Fluency in French and English is mandatory (spoken and written English)
Excellent command of Microsoft office software’s
High organizational and communication skills, good interpersonal skills, flexibility in tasks and schedules
Sense of responsibility, enthusiasm, diplomacy and team spirit
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.
As our Automation Expert, you will ensure good engineering practices and design put in place to make sure our new Manufacturing Plant project meets the company expectations and strategy for all assigned packages. You will also implement tactical strategies in a lean and efficient way. You track and report the progress up to the support model strategy implementation.
Your responsibilities?
Ensure good engineering practices for automation
Ensure for your packages that deliverables will be provided timely and aligned with project planning with the right expected quality and according to the allocated budget
Collaborate closely with Automation Integrator company
Align design expectations with the other project disciplines : process, automation, QA, C&V, E&I,…
Manager consultant engineers tems and sub-contractors to implement tactical automation strategy
Align and translate process strategies (production, cleaning, sterilization) between process equipment and automation systems
Align design expectations with the other
During plant operation, ensure plant support in term of automation and troubleshooting
Anticipate, manage and report risks from Detail Design till validation batches
Verify project documentation coming from Engineering Company and Automation
Integrator
Challenge process design to ensure alignment between equipment
Participate and define overall automation strategy for our new BioManufacturing Plant (Library, Recipe structure, HMI philosophy, reporting, alarm strategy, etc.)
Manage the team of Engineers to deploy automation strategy
Follow ‘up Automation Integrator and Vendor Packages during development and execution
Verify automation deliverables and anticipate any cost increase
Proactively report and manage risks
Organize operator training
Perform handover to operation and support team
Manage punch list related to its packages
Translate process improvement / modifications into automation requirements
Ensure efficient handover to operation teams and ensure they will be trained to operate the automated installation
After handover be part of the Automation Engineering local team and support manufacturing activities (24/24 guard)
Support and troubleshoot installations to guarantee process Drug Substance manufacturing
Your profile?
Industrial or Civil Engineer Degree
Experienced in Engineering projects in GMP environment
Minimum 5 years’ experience in Bio-Process and/or Automation
Proven involvement in significant major engineering projects, including risk/mitigation management
Goof level of French and English
Strong knowledge of cGMP
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
Able to reach team decision and high sense of responsibility
Ability to challenge and argument
Ready to travel a limited period of time
What can you expect?
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. Do you have any questions? You can contact Anaïs Malikian, [email protected]
Les Responsabilités – Définir et assurer le suivi des stratégies de qualification CSV qui touchent au projet OMP – Identifier l’approche d’implémentation de ces stratégies (Change Control, autres) – Déterminer les impacts validation sur base des release notes du fournisseur – Évaluer la compatibilité avec les logiciels / micrologiciels existants – Comprendre, appliquer et communiquer sur les prérequis de validation – Identifier et contrôler les risques inhérents au projet – Rédiger les documents de qualification conformément aux SOP – Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet – Exécuter et/ou vérifier les tests de qualification des installations en impliquant les futurs utilisateurs et/ou le fournisseur et conformément aux procédures en vigueur – Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation ou le déroulement de la mission – Supporter ou prendre à charge des activités liées à de l’amélioration continue – Assurer le respect de la législation et des normes en vigueur ainsi que des règles de sécurité interne. Cette liste est non-exhaustive et sera amenée à évoluer en fonction de l’avancement du projet. Par ailleurs, la personne pourra compléter des périodes plus calmes par la gestion des activités de qualification/validation CSV liés au projet automation en cours (autre que ceux d’OMP), soit : o Définir et assurer le suivi des stratégies de qualification/validation CSV. o Evaluer l’impact qualification inhérent au risques identifiés. o Rédiger les documents de qualification conformément aux SOP de qualification / validation. o Identifier l’approche d’implémentation de ces stratégies (Change Control, autres). o Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet. o Exécuter et/ou vérifier les tests de qualification / validation des installations en impliquant les futurs utilisateurs et conformément aux procédures en vigueur. o Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation des dits projets éventuels. o Donner le support CSV aux activités du département Site Process Validation (gestion de déviations, CAPA, préparation et/ou participation aux audits, …). o Mettre à profit son expertise CSV afin de répondre à des sujets spécifiques (position papers, analyses de risque, …) En fonction des priorités des projets et de l’évolution de ceux-ci, la charge de travail pourra évoluer.
Expertise et Connaissances Requises – Bachelor / Master de préférence à orientation informatique/automation industrielle et autrement, dans un domaine scientifique. – Au minimum 05 ans d’expérience dans le domaine de la validation dont au moins 03 ans sur les systèmes automatisés et/ou informatisés et en particulier sur des mises à jour / upgrade / revamping de software / firmware. – Compréhension des flux, des pratiques, des méthodologies et des délivrables de validation. – Connaissance confirmée de la partie automation des procédés industriels pharmaceutiques (laveuses, testeurs de gants, RABS, isolateur, sertisseuse, remplisseuse, scelleuse, tunnel de dépyro, autoclave, testeurs de filtres, stations CIP/SIP, centrales d’acquisition comprimeuse, mélangeur, système d’inspection visuel, système de sérialisation). – Connaissance confirmée de la partie équipements de laboratoire (RMN, électrophorèses, spectro UV Vis, Spectro FTIR, qPCR, MALDI TOF etc.). – Connaissances des paramètres et éléments de conception pouvant avoir un impact qualité sur les procédés susmentionnés. – Connaissance des techniques en IT/Computer System Validation. – Compréhension et facilité d’expression en anglais. – Capacité à prendre des responsabilités et des décisions. – Capacité à entretenir de bonnes relations avec les acteurs du projet. – Capacité de persuasion et compétence d’assertivité. – Rechercher et analyser les causes de défaillances, et proposer des solutions innovantes pour y remédier. – Capacité à établir des liens entre les concepts et à faire preuve de recul (helicopter view). – Autonome et flexible. – Faculté à comprendre, à suivre et à faire siennes les décisions prises avec le line manager. – Esprit analytique et capacité de raisonnement logique marquée. – Méthodique, rigoureux, proactif et organisé. – Orienté(e) qualité et client (manager CSV). – Facilité à travailler en équipe et à soutenir ses collègues, à communiquer et à parler d’une seule et même voix. – Franchise, éthique, honnêteté, respect & intégrité. – Capacité à coordonner différents projets en même temps.
Notre Offre Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .
Automation Engineer Contracting – Braine l’Alleud The Responsibilities
Verify project documentation coming from Engineering Company and Automation Integrator.
Challenge process design to ensure alignment between equipment.
Participate and define overall automation strategy for our new BioManufacturing Plant (Library, Recipe structure, HMI philosophy, reporting, alarm strategy, etc.)
Manage the team of Engineers to deploy automation strategy.
Follow ‘up Automation Integrator and Vendor Packages during development and execution.
Verify automation deliverables and anticipate any cost increase.
Proactively report and manage risks.
Organize operator training.
Perform handover to operation and support team.
Manage punch list related to its packages.
Translate process improvement / modifications into automation requirements.
Ensure efficient handover to operation teams and ensure they will be trained to operate the automated installation.
After handover be part of the Automation Engineering local team and support manufacturing activities (24/24 guard)
Support and troubleshoot installations to guarantee process Drug Substance manufacturing.
Skills and Knowledge Requirements
Minimum 5 years’ experience in Bioprocess and/or Automation
Proven involvement in significant major engineering projects, including risk/mitigation management.
Goof level of French and English
Strong knowledge of cGMP
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.
Able to reach team decision and high sense of responsibility.
Ability to challenge and argument.
Ready to travel a limited period of time.
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.
As a Clinical Drug Delivery Device Lead, you will report to the Head of Device Transversal Services and you will work as a subject matter expert to select and/or assess drug delivery devices used in clinical trials (ie. injection pumps, infusion lines and bags, needles and syringes for iv and sc administrations, oral syringes and dosing cup, etc…). You will be part of a global and highly collaborative multidisciplinary team. What you’ll do
Define and implement the overall strategy for the various drug delivery devices to be used in the clinical trials.
Work with a cross-functional team (including clinical, QA, RA, safety and SME teams) to ensure timely support to clinical trials.
Lead the Clinical Drug Delivery Devices sub-teams to ensure appropriate selection and assessment of drug delivery devices to be used in the clinical trials.
Perform the technical assessment for devices used in clinical trials and selected by our CROs.
Who are you ?
A master’s degree with a relevant academic background, ideally a nurse or a physician
8+ years of experience in a clinical drug delivery devices selection
Very good knowledge of medical devices and pharmaceutical environments
Experience in clinical trials set-up
Understanding of the issues and challenges of selecting appropriate and fit for purpose devices from FIH to Phase 4 clinical trials studies
Thorough knowledge and understanding of Medical Devices Regulations (EU MDR, 21CFR part 820, ISO13485) and in GxP (GMP and GCP)
Experience in drug-device compatibility testing and material of contact assessment is a plus
Project management skills
Leading and influencing cross-functional and matrix teams
Excellent writing skills
Autonomous and detail oriented
What can you expect ?
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.
We are looking for a Manufacturing Sciences & Technology (MSAT) Lab Scientist who is dynamic, experienced, and collaborative to join our Global Biologics MSAT team, based at our campus in Braine-l’Alleud, Belgium.
The Responsibilities
Conducting cell culture experiments (including cell expansion, mAb production in glass and single use benchtop bioreactors)
Providing cell culture lab support for Technology Transfers, Process Validations, Manufacturing operations and deviations/investigations as required, by execution of appropriate cell culture experiments within MSAT.
Working with the MSAT Lab team to deliver cell culture milestones.
Establish close partnership with development and commercial manufacturing groups worldwide, serving as a representative of the department in cross-functional project teams.
Adhere to the company’s Health, Safety & Environment (HSE) policies.
Coordinate, design, and execute lab experiments applying Quality by Design standards and resources.
Ensure accurate documentation of experimental protocols, data, and reports.
Support the development and update of MSAT lab policies and procedures.
Provide cell culture lab support for technology transfers, process validations, and manufacturing operations.
The Skills and Knowledge Requirements
An M.Sc. degree in Biology, Biotechnology, Chemical Engineering, or a related discipline
A track record in cell culture activities
3 – 5 years of experience in cell culture
Excellent problem-solving and communication skills
Fluency in English is mandatory, with knowledge of French being advantageous.
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.
Project Engineering Lead Contracting – Braine l’Alleud
The Responsibilities
Is accountable of the design and execution of his projects – mainly in management of some different projects/program (multiple/interaction management of dashboard, status advancement and health for each project/program).
Coordinate and manage activities with partner (engineering company) during projects design & execution (all portfolio of projects/program will be produced with Engineering company).
Coordinate all technical activities and planning for execution of a project.
Have a larger understanding of all related disciplines to challenge/review globally and identify potential issues.
Have a relevant or previous experience in Pharma (rules GXP, GMP or GLP) and have expertise in Integrate (Planisware SW) Infrastructure, Security or Annex 01 is a must.
Is also person of reference of overall project activities – cost, schedule, quality, risk mgmt., Gate mgnt,…
Project point of contact with management, business clients, external or engineering companies and technical team.
Alignment with global standards – technical, green, safety, GMP, …
Partnering with engineering firms to ensure proper support in delivering the project designs & execution.
Working with our Business Expert to define the best solution to meet customer needs.
Managing cost and planning for all engineering projects activities.
Managing Basic / Detailed design and execution.
Ensuring resources identified without gaps nor overlap.
Handling project governance, budget controlling in accordance with PMO requirements (dashboard of multiple projects).
Overseeing the project team supervision (with Engineering company).
Consolidating and reviewing specifications (e.g. URS, Technical Specifications) with team project members and Engineering company.
Ensuring strong communication with stakeholders and Engineering company.
Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement, and collaboration.
Dealing project engineering package of medium to high complexity.
Skills and Knowledge requirements
Ability to take initiative and work in a team environment.
Strong value commitment.
Experience in (complex/multiple) projects.
Both formal and informal leadership / coordination.
Experience with deployment of EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models.
Manages with a matrix of reporting lines and across functional areas.
Ability to share good practices and knowledge.
Excellent communication skills and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
Leadership experience for the management of internal and external resources.
Ability to apply previous learning and ideas to new situations, projects, and teams, developing creative solutions to manage risk to a reasonably practicable level.
Strong reporting, interpersonal and leadership skills.
Able to translate customers’ needs in projects requirements.
Full professional proficiency in French and English (both oral and written).
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.
The Responsibilities • Independently design and execute pharmacokinetic studies, analyze, and interpret data, and presenting findings back to project teams • Recommend and lead new strategies within the DMPK department • Apply your understanding of surgical techniques to provide mechanistic study support for our projects • Develop and implement state-of-the-art technologies
Skills and Knowledge Required • A degree in biological sciences or related discipline, PhD would be advantageous • Demonstrate experience with a range of in vivo DMPK models • Experience in the pharma or CRO industry with hands on experience of in vivo ADME activities in drug discovery support. This will include routine and mechanistic investigations to support the understanding of the clearance and disposition of new drugs. • Knowledge of the range of ADME and analytical methods available to drug projects • Be able to demonstrate the ability to collaborate and influence in a multidisciplinary team • Publication and presentation record • FELASA B Belgium personal license for in vivo work
Our Offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
The Responsibilities • Is accountable of the design and execution of his projects – mainly in management of some different projects/program (multiple/interaction management of dashboard, status advancement and health for each project/program). • Coordinate and manage activities with partner (engineering company) during projects design & execution (all portfolio of projects/program will be produced with Engineering company). • Coordinate all technical activities and planning for execution of a project. • Have a larger understanding of all related disciplines to challenge/review globally and identify potential issues. • Have a relevant or previous experience in Pharma (rules GXP, GMP or GLP) and have expertise in Intregrate (Planisware SW) Infrastructure, Security or Annex 01 is a must. • Is also person of reference of overall project activities – cost, schedule, quality, risk mgmt, Gate mgnt,… • Project point of contact with management, business clients, external or engineering companies and technical team. • Alignment with global standards – technical, green, safety, GMP, … • Partnering with engineering firms to ensure proper support in delivering the project designs & execution. • Working with our Business Expert to define the best solution to meet customer needs. • Managing cost and planning for all engineering projects activities. • Managing Basic / Detailed design and execution. • Ensuring resources identified without gaps nor overlap. • Handling project governance, budget controlling in accordance with PMO requirements (dashboard of multiple projects). • Overseeing the project team supervision (with Engineering company) • Consolidating and reviewing specifications (e.g., URS, Technical Specifications) with team project members and Engineering company. • Ensuring strong communication with stakeholders and Engineering company. • Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement, and collaboration. • Dealing project engineering package of medium to high complexity.
Skills and Knowledge Requirements • Ability to take initiative and work in a team environment. • Strong value commitment. • Experience in (complex/multiple) projects. • Both formal and informal leadership / coordination. • Experience with deployment of EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models. • Manages with a matrix of reporting lines and across functional areas. • Ability to share good practices and knowledge. • Excellent communication skills and ability to prioritize multiple tasks and to work on multiple projects simultaneously. • Leadership experience for the management of internal and external resources. • Ability to apply previous learning and ideas to new situations, projects and teams, developing creative solutions to manage risk to a reasonably practicable level. • Strong reporting, interpersonal and leadership skills. • Able to translate customers’ needs in projects requirements. • Full professional proficiency in French and English (both oral and written).
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Our partner is looking for a Process Workstream Lead to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
TECHNICAL SKILLS
Lead the engineering process team and act as the spoc for all process equipment from design until the handover after verification. Organize his/her team to address to address the best engineering good practice and collaborate with key users.
He/She is in the driver seat, with a full management of supplier, User, QA, EHS, C&V team and will be measure with the success of process equipment implementation.
Strong background within manufacturing USP & DSP (upstream & downstream) bioprocess equipment (Single use systems: bioreactors, UF/DF filtration skids, Chromatography skids, ATF, Mixer), Fill and finish, autoclave and washer.
Expert of single use equipment and aseptic used
Strong knowledge on GEP and global engineering standards.
Ability to Lead P&ID and PFD setup is required, as well as mass balances, FS, HSD, SDS,…
Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
Knowledge and expertise in verification ASTM E2500
Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
Experience in large and complex projects as well as both formal and informal leadership / coordination
Capable to benchmark with peers in the industry and able to identify latest trends
Excellent communication skills in order to present frequent reports to Management.
BASIC & DETAILED DESIGN
Define the applicable standards/norms/engineering guidelines for the project
Provide Engineering offices with the applicable standards
Challenge technical solutions coming from Engineering office
Integrate safety, sustainability and green assessment in the design
Define List of Delivrables for his discipline
Provide project delivrables of his discipline to Engineering Leader
Follow-up on progress/ ETC.
CONSTRUCTION
Based on progress report of the construction manager, perform on a regular basis field spot check follow-up
Organize quality checks on field before each technical milestone activiy.
Communicate the day to day schedule (planning level 4) to the Engineering Leader and construction manager
Ensure a good communication with other Specialists linked to its activity (Battery limits)
Maintain his knowledge accuracy based on new technology. Keep up-to-date
Documentation
Define battery limit and RACI matrix with Engineering Leader
Update drawings in its area of expertise
Write commissioning documentation and ensure that the supplier's documentation is acceptable to perform verification (ASTM 2500)
Perform FAT/SAT activities in its area of expertise
Support the qualification phases after commissioning (V-Cycle and/or ASTM2500)
Organize the training of the final user in its area of expertise & provide technical documentation in to finalize the Hand-over
Actively perfom the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist
Respect documentation strategy
HSE
Ensure compliance to HSE requirements and rules
Ensure the 3 green lights are scheduled and correctly organized/done
Who are you ?
Master's Degree
Minimum 10 years of experience within pharmaceutical companies and working on CAPEX large projects.
Dynamic person with strong value commitment & resilient Strong Process Technical expertise
Fluent in English is mandatory. French is highly desirable.
Good Knowledge of cGxP requirements
GEP – Good engineering practice expertise
Excellent communication skills (able to present to Management, Engineering office, User and others) and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
Team player, Rigorous, Accountable, Involved, Proactive.
Pragmatic to solve issues; solution oriented with a positive mindset
Autonomous, fully acting at own's initiative.
Broad Leadership experience for the management of internal and external resources.
Ability to apply previous learning and ideas to new situations, projects and teams, developing creative solutions to manage risk to a reasonably practicable level.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Able to both take direction and mentor other team members
Able to translate customers’ needs in technical requirements
Open to travel to support UCB strategic international projects
What can you expect ?
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.
