About our client Our client is looking to strengthen their team within the Center of Excellence in Validation with the support of a Junior Validation Engineer.
Your responsibilities Within the center of excellence in validation at LMSAT the responsibilities will be:
Support the improvement program regarding filters and filtration management, participate in the documentation review, including validation plans, protocols, reports, and standard operating procedures (SOPs).
Perform gap assessment between different documents and between documents and practices in the field. Propose improvement and simplification following observations.
Using current procedure and state of the art knowledge, contribute to build educational materials on validation topics.
Collect data across different system to build a database related with validation activities.
For a given situation, use available data and statistical tools to calculate operational ranges and min or maximum values as needed.
Executing validation protocols for equipment, systems, and processes, documenting each step to provide a comprehensive record.
Collaborate closely with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure all activities are performed in accordance with current Good Manufacturing Practices (cGMP) and other relevant guidelines.
Stay updated with industry trends, regulatory updates, and technological advancements to contribute to the development of best practices and innovative validation methodologies within the pharmaceutical manufacturing.
Skills and knowledge requirements
You have a bachelor’s or master’s degree in science or equivalent by experience.
You have an experience with equipment and process validation in the pharmaceutical industry.
You have a good knowledge of GMP regulations.
You have a good knowledge of aseptic technologies and viral processes.
You like to work in a team and are quality oriented.
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 Senior validation engineer to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities. Write and coordinate approval of change controls related to technical modifications.
Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
Establish and monitor validation KPIs.
Review handover of equipment / systems from suppliers and or other project stakeholders.
Who are you ?
More than 5 years of experience with PQ phase having led and managed validation projects, including sterile manufacturing.
Must have experience of working on projects; project management experience. We need someone who understands and knows what to do but not a PM expert.
Knowledge of safety, GMP and environmental regulatory requirements.
Expert in reviewing and writing technical reports.
EN is a must have
Ability to work with other persons – team spirit.
Homeworking : authorized, but must remain flexible according to project needs.
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.
GMP compliance Our client Our client is looking for a profile in GMP Compliance to join its team. The QA Spare parts is part of the QA for Technical Services. They ensure the QA oversight of the spare parts warehouse.
Your responsibilities – Release spare parts to be used on GMP equipment throughout the company plant. – Contact the spare parts' supplier in case of further investigation to allow release of the spare parts. – Ensure on the floor presence and be the point of contact for the operational team. – Participate to the strategy definition of the spare parts management and release. – Ensure the correct application of the quality systems on the field and to define improvement plan as required. – Process the backlog in release, investigations, and archives. – Challenge the new spare parts creations. – Review the modification proposed by the technical teams (MO). – Quickly understand the regulatory requirements for the spare parts – Use a risk-based approach for problem solving and prioritization of tasks – Blow a quality and compliance mindset through the operational team – Develop and continuously improve expertise linked to spare parts – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
Skills and knowledge requirements – University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) – At least 5 years professional experience in pharmaceutical environment. – Very good interpersonal relationship skills – To be a good team player in order to success in each validation project. – Fluent in French, good oral and written communication skills in English – Problem solving and achievement oriented – Knowledge of GMP Regulated environment – Strong organizational skills
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]
What are the responsibilities? Follow up the review of the Change Proposals and impact assessment documentation covering E2E Artwork & Labelling process :
acknowledgement of change proposal reception
preparation of the kick off meetings in the context of change proposals
follow up the review of the change and impact assessment for Artwork
communication to stakeholders and change leader based on endorsement of the change in the context of Artwork
tracking of CP projects to ensure endorsement is done on time
Create and manage AW projects in artwork management system:
creation & scheduling of artworks projects;
performing AW Project Coordinator’s tasks as defined in AW management system;
coordination and tracking of the artwork creation and approval; follow-up of all project tasks to deliver the approved artworks respecting cross-functionally agreed timelines and other project due dates; keep the dues dates in the system up to date;
working in close collaboration with all involved internal and external stakeholders of the artwork projects.
mockup GARF approval, create and manage MU projects in artwork management system;
closing AW projects and GARF projects;
tracking of AW projects to ensure that tasks are completed on time and are kept aligned with deliverable expectations.
Experience and Knowledge requirement
Bachelor's degree or equivalent experience
Excellent computer literacy;
Experience in coordination and administrative tasks
Good communications skills and team spirit
Used to work in a multinational/multicultural environment
Fluent in English (written and oral), French is an asset
Experience from a Regulatory and/or Supply Chain environment is an asset.
Service minded with very good written and verbal communication skills
Problem solver
Structured, detail minded and well organized
Stress resistant, accepts to be challenged and to challenge others
Open minded, flexible and team oriented; capable of doing the extra mile to reach targets.
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 me.
Purpose of the Mission Engineering is primarily concerned with the installation and application of developed solutions, the maintenance of facilities, infrastructure, and equipment as well as the connection of services (water, chemicals, gases). Any other aspect in engineering like plant design, industrial programming, etc… may be concerned.
Primary Tasks & Responsibilities • Individually or as part of a project team responsible for solution design and process layouts for electricity and instrumentation equipment including the following installations: instrumentation and machinery for power generation, power supply, electrical protection, small cabling, calibration and measuring devices, Telecom equipment (data, Wifi, Deadman) and electrical distribution MT (36-11kV) and BT (400-230V-48V-24V). • Responsible for the execution, coordination and follow-up of solution designs and technical matters related to Process Control to ensure construction, transformation, commissioning, and qualification of the solution meets agreed cost, timing, technology, and quality standards in line with the Global Technical Services standards. • Key activities include: o Define functional, technical, and quality requirements. o Realize process studies, P&ID’s and process layouts whilst considering the operating and EHS characteristics at all design steps. o Ensure preparation and update of the project qualification and coordinate qualification activities of the installations. o Ensure work inspections are issued in line with quality standards. o Ensure systems legal conformity. o Coordinate technicians during execution to secure contracts and connection of services (water, chemicals, gases) and electricity.
Experience, Knowledge & Soft Skill Requirements • Demonstrates deep knowledge in design and implementation of engineering projects. • Practical experience in project supervision and people management • Perform his/her work in a cGMP consistent manner. • Experience in the Pharmaceutical industry
Soft Skills: • Good communication skills • Good project management skills: organization, cost, time, schedule, contracting, procurement, qualification, validation, technologies.
Education, Methodology & Certification Requirements • Industrial or Civil Engineer.
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 SME E&I to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Act as the technical reference for contracts related to its area of expertise.
Expert in his/her field of expertise
Author of specifications, calculations and drawings relating to his field of expertise
SPOC for contractors selected to build the facility in his field
Collaborate with the company package owner to manage the contract: planning, budget, quality of execution.
Who are you ?
Knowledge in electricity, high and low current. Experience in electricity in the pharma field (data, access control, …).
Proven experience in CAPEX projects
5+ years of experience in engineering for industrial and/or pharmaceutical environments
Experience in the biotech environment in the bio-pharmaceutical industry is preferred.
Knowledge of safety, GMP, and environmental regulatory requirements.
Experience in legal conformity and energization process (3 green lights), proven experience in qualification
• Soft skills:
Senior profile, minimum 10 years of experience in the field.
Proven experience in qualification; knowledge of Verification (ASTM E2500) is a plus
Good communication, rigorous, fully capable of acting on own initiative
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.
Vos responsabilités ? L’équipe Supply assure les différents flux logistiques et supporte les activités de productions. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP du BioPilot. Ils contribuent à la gestion de la logistique (Commandes, réceptions, transferts entre magasins, vêtements de travail, approvisionnement de matières, élimination de déchets,…).
Coordination de projet – implémentation de XFP
Être le point de contact pour le projet d’implémentation de XFP
Prendre le lead et suivre les actions bloquantes ou en attente pour l’implémentation de XFP
Diriger ou soutenir l’implémentation de solution relatif à l’implémentation de XFP
Former les équipes opérationnelles à l’utilisation de XFP
Participer à l’écriture, la mise à jour des procédures impactées par l’implémentation de XFP
Soutenir l'équipe opérationnelle pour la fabrication de DS après la mise en oeuvre de XFP
Votre profil ?
Très bonne connaissance de SAP
Bonne connaissance Excel, Word, Powerpoint
Expérience dans le contact fournisseur
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.
Associate Scientist Our client is looking for a Associate Scientist to join its team. The team is based both in Slough and Braine and is responsible for developing processes – scale up and piloting of the processes (cell-culture processes – focused on the upstream side of the process). One important aspect is harvesting – once the cells are grown in the bioreactor, and they get them to express the product, the team has to crude purification to remove cells from the product. The type of cells are CHO cells. Another aspect is understanding the scaleup and the transfer to the next scale of the manufacturing in the BPP biopilot (GMP facility).
In short, growing cells, developing the process, keeping them healthy and getting them to express the biologic molecule that is then purified and eventually reaches the patient.
Working with: • Benchtop bioreactors systems, such as Amba systems, Sartorius, • Larger scale piloting systems • single-use bioreactors • shake flasks, • anything on which cell process can be run
What are the responsibilities? The position is primarily lab-based: – A mix of documentation. – Preparing the protocol and the documents. – Preparing the experimental designs and preparing the experiments. – Making buffers – Preparing meetings. – Building bioreactor vessels – Sterilizing equipment – Running the bioreactor – Keeping the cells nice and healthy throughout the whole process – Monitoring, measuring, taking samples, recovering the product – Doing harvest and clarification – Working with colleagues from other departments. Experience and Knowledge requirement Must have – Process development experience – Knowledge of cell culture and bioreactor processes (any scale, pilot scale preferably) – Experience with benchtop bioreactors systems, such as Amba systems, Sartorius, larger scale piloting systems, single-use bioreactors, shake flasks, aseptic techniques, etc. – Minimum 2 years of experience – Fully fluent in English, French is a nice to have
Nice to have – Knowledge/experience with harvesting and clarifying processes – clarification, centrifugation, centrifuge operations, filtration – Experience with antibody expression, recombinant protein expression – GMP experience
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]
R&D clinical Contracting – Braine l’Alleud Our client is looking for a profile to fill a position in R&D clinical development. The role involves clinical studies in F1 and F2.
What are the responsibilities? • Activities related to the design, and everything related to the analytical development. • Taking the lead on protocols studies
Experience and Knowledge requirement • Proven project management skills • Experience in medical monitor for vaccines studies • Degree or background in the medical field or proven experience • Nice to have: clinical method development plan management • Fully fluent in English both written and spoken
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]
Sites and Infrastructures Partner Our client is looking for a Sites and infrastructure Partner to join its team. The role Sites and infrastructure Business Engineering Partners serve as the central point of contact and a robust bridge connecting the Business area, Engineering, and Project Leaders for various facilities infrastructure aspects (such as buildings, roads, parking, landscaping….). The role includes:
Strategic Perspective: Consolidate the overall technical perspective of thebusiness area.
Budget and Feasibility: Accountable for delivering feasibility and design studies.within the budget for the 10-year plan.
CAPEX Coordination
Engineering Support: Sites and infrastructure Business Engineering Partnerscoach and mentor Engineering Managers, ensuring strong technical deliverables forCAPEX Projects.
Resource Allocation
What are the responsibilities?
Understanding Customer Needs:
Gather and comprehend requirements from customers.
Assist customers in articulating their needs to create a GP0 (General
Proposal).
Scenario Development:
Think creatively and prepare various scenarios.
Present these scenarios to stakeholders.
Project Initiation (GP0 Approval)
Support the Sponsor or Idea Owner in launching the project.
Collaborate with the Technical Engineering Team to identify the Project
Leader (PL) and establish the team structure for GP1 (Detailed Proposal).
Drive the project toward achieving GP1.
Coach the Project Leader on following the methodology.
Participate in Project Steering Committee (SteerCo) meetings.
Connecting Customers and Global Engineering:
Serve as the liaison between customers and the Global Engineering
structure.
Communicate customer requests to the engineering team.
Assist the engineering team in resource allocation, technology planning, and
high-level resource needs.
Relay project-related issues from Engineering to customers (Global
information).
Monitor and facilitate the handover process.
Experience and Knowledge requirement
Minimum 5 years in Infrastructure projects like Project Leader or Team Manager
Minimum 1 years within chemical, pharmaceutical or biotech company with minimum technical background (process and utilities).
People management with a minimum of 2 years in a Production/engineering environment as supervisor or manager.
Project management with a minimum of 5 capital projects succefully delivered and experience in capital project management up to min 10 mioEUR.
Experience in risk management (and related specific tools (FMEA, HAZOP)
Experience in capital and asset management is an asset.
Experience in Masterplan building
Fully fluent in English and French
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]