Our client is looking for CVS expert to join its team.
What does the team do? Part of the IT Compliance Solution team responsible for all the validation of IT computerized systems across the company. There are 5 IT Compliance Leads for each particular domain. Each monitors oversees a team of validations CSV Experts (SMEs) who are working on the day-to-day activities (on the actual validation work)
What are the responsibilities ?
Task / Daily activities: • Accountable for the validation strategy for the systems in their scope • Overseeing everything related to the projects’ submission – review the project charter, assign the resources, establish the strategy for the validation • Reviewing/approving documentation • Management of the resources • Doing everything related to the compliance of the systems – change management, periodic review, deviation procedures update, etc.
Experience and Knowledge requirement
Years of experience in the position: min 5 years of experience
Must have criteria (focus on hard skills/specific tools experience)
• Expertise in validation – need to have an understanding of validation strategy and be able to establish a validation strategy by themselves (autonomy required)/ Ability to manage/review project
Nice to have criteria: • Veeva Suite (for the document and deviation management) • ITSM for incident management • Trackwise, Sharepoint, etc.
Mandatory language: English (French is a plus)
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]
Managing and keeping up to date the master documentation list and links within the Veeva electronic Content Management System (eCMS)
Contributing to writing/reviewing of procedural documents including SOP, work instructions, templates, forms, … while checking consistency across the quality system, ensuring compliance to Documentation Management SOPs, ISO13485 and 21 CFR Part 4, and implementing the SOP Simplification Best practices
Creating or updating process flows using iGrafx software and reviewing documents’ meta data
Managing KPIs with monthly extracts, preparation of data and presentation of reports
Monitoring and following up with action owners and document owners from other departments
Supporting preparation and management of inspections
Supporting eQMS implementation by participating in validation activities
Support the quality improvement culture
Are you the candidate we're looking for?
The candidate will need to be :
Proficiency in English (written and spoken) is required – French is a bonus
Organized, rigorous on details and on keeping to deadlines, quickly learn to use several documentation tools
Able to ask more senior colleagues to progress their work
Show some initiative within the scope of work.
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺ We can't wait to meet you, so don't wait any longer!
Prepares and present scenarios to management for strategic decisions.
Delivers Feasibility and Early Design: user requirement brief, technical deliverables, budget, schedule, risks, alternative, prioritization
Transfers the feasibilities to the Delivery department in compliance with the governance
Assists Business Investment Partners:
Collecting user and site requirements
Completing the Project Ranking Forms
Establishing the project portfolio in the form of an investment plan
Contributes to the robustness of 10YP (investment plan) and robustness of the Sites Master Plans
Propose technical solutions in order to:
Optimize capital expenditure
Ensure stakeholders satisfaction
Guarantee safety of people
Reach our 2030 environmental objectives: carbon neutral &reducing our water consumption by 20%.
Connect with his peers to have a deep understanding of the different Masterplans (Networks, Manufacturing, Laboratories…) Portfolio size:
+/- 50 projects.
CAPEX: 100 M€.
Main customers: Site Managers, Head of Sites, Facility Management.
Geographical: Braine (BE), Bulle (CH)
Scope: This role supports all Capital Investment decisions and CAPEX Projects for the Business area.
Are you the candidate we're looking for?
Master's degree
Minimum 10 years in industry within technical project Leader or equivalent Minimum 5 years within chemical, pharmaceutical
Benchmarking in pharmaceutical manufacturing processes (chemistery, fermentation, isolation, purification, fill and finish, galenic, medical devices, cold storage, packaging …)
Expertise in chemical and pharmaceutical standards
Expertise in cGMP, Green and HSE standards
Good analytical impact on the bussiness/legal rules. Fluent in French and English.
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!
En tant que responsable R&D d’une société agroalimentaire, vous possédez une expertise en optimisation des processus et en suivi commercial des retours clients et des fiches techniques.
Quelles sont vos responsabilités ? En tant que responsable R&D, voici une partie de vos responsabilités :
Vous analysez en profondeur les retours clients afin de comprendre leurs attentes et préférences, puis transformez ces informations en actions ciblées pour améliorer les produits. Vous rédiger et maintenez à jour les fiches techniques des produits. Vous gérez avec précision les fiches techniques des fournisseurs pour assurer la qualité de la documentation technique. Vous collaborez étroitement avec l'équipe commerciale en fournissant un soutien technique aux clients et en identifiant de nouvelles opportunités commerciales. Vous contribuez activement au développement de nouveaux produits en proposant des solutions innovantes en accord avec les besoins du marché.
Qui êtes-vous ? Vous êtes titulaire d'un diplôme d'ingénieur, de préférence dans le secteur agroalimentaire, biochimie ou chimie analytique ; Vous avez une maîtrise parfaite de la langue française et une bonne connaissance de l’anglais. La connaissance du néerlandais est un reel atout ; Vous justifiez d'environ 5 ans d'expérience dans une fonction similaire dans le secteur agroalimentaire ; Vous possédez une bonne connaissance des normes HACCP ; Vous êtes compétent dans l'utilisation de SAP et de la suite Microsoft ; Vous êtes capable de travailler de manière autonome tout en ayant un esprit d'équipe prononcé ; Vous êtes axé sur le client, flexible, proactif et résistant au stress.
Que pouvez-vous espérer ? Vous rejoignez une entreprise dynamique et contribuez à façonner l'avenir d’une entreprise agroalimentaire en tant que responsible R&D. Ce poste offre une opportunité exceptionnelle de laisser votre empreinte dans un environnement passionnant et en constante évolution. Vous recevrez un package salarial attractif selon votre expérience. Intéressé(e) de relever le défi ? N’hésitez plus et postulez à l’adresse suivante : [email protected]. Nous n’attendons plus que votre candidature pour discuter de cette fonction polyvalente !
Lead the DSP team to deliver the activities in the day to day from End of detailed Design with Automation document to the end of the first product run
TECHNICAL SKILLS
Experience with EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models is mandatory
Strong background within manufacturing DSP (downstream) process equipment (Single use filtration skids, Single use Chromatography skids, Single use UFDF and VRF, Single use mixer)
Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams), FS (Functional specification) and PFD (Process Flow Diagrams) is required, as well as mass balances.
Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
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
URS
Review the URS provided by the Engineering Office in order to ensure all User requirements are fully respected
Include all technical requests in the URS for the commissioning and qualification.
DETAILED DESIGN
Provide Engineering offices with the applicable standards
Review PFD and P&ID
Review and participate in the technical specs and datasheets from Engineering Office
Review Functionnal specification for Automation from Engineering Office
Challenge technical solutions coming from Engineering office
Integrate safety, sustainability and green assessment in the design
Follow-up and challenges of the engineering office
Commissioning, Qualification& Verification
Perform Design review and Design Verification with the Engineering office and the CQV team
Lead and Participate to the FAT/SAT of Equipments in the scope
Support the qualification phases after commissioning (ASTM2500)
Organize quality checks on field before each technical milestone activiy.
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
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 schedulled and correctly organized/done
Leadership
Lead the DSP team to deliver the activities in the day to day from End of detailed Design with Automation document to the end of the first product run
Are you the candidate we're looking for?
Master's degree
Minimum 15 years of experience within pharmaceutical companies and working with Engineering offices
Manage a fluent communication between different stakeholders (Engineering office, User and others)
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!
Individually or as part of a project team responsible for the application of all legal, Health and Safety rules on large construction sites and rebuild projects with a specific focus to enforce and monitor regulations.
Work in close coordination with the EHS team, engineering offices, safety advisors and construction managers to audit and report on contractors safety performance.
Responsible for safety performed within the construction department including but not limited to:
monitor the activities of subcontractors to ensure compliance with safety and health regulations and procedures.
ensure all safety codes, requirements and standards are being complied within assigned area of responsibility (Health and Safety plan, risk analysis, mitigation measures and safe plan of action).
implement corporate safety policies, procedures and instructions within assigned operations.
prepare and review construction methods and procedures in light of safety and health regulations.
Your profile?
Technical degree or relevant experience (10 years in construction, of which 5 years as safety advisor/manager
Complementary EHS certification relevant to safety coordination on construction site
Project and people management skills with thorough knowledge of construction
Aware of risk policies and sensitive to workers' attitudes toward these policies
Ability to work and communicate in a complex environment involving contractors and engineering offices from various countries
Perform his/her work in a cGMP consistent manner
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.
Our partner is looking for a QA GDP to join its team. The purpose of the mission is to support the Quality for Supply Chain team, being a quality partner for some of the distribution related activities. The mission also consists in supporting the operational quality assurance management of Wade Distribution Center. The objective is to ensure the continuous supply of vaccines in line with regulatory, quality and business objectives to meet customer needs.
What are the responsibilities? Quality partner for deviations: • Be the QA representative for CAPA on Wade operations, ensuring those are properly performed, following relevant procedures. Ensure implementation follow up is performed and escalation process is properly applied when needed. • Support the monitoring of quality KPIs for Wade distribution center related activities through the preparation / lead of the monthly quality governance meeting (Quality Council). Ensure that periodical reviews are performed, and negative trends are properly remediated and escalated as required. • Support archiving management of QA documents in Wade • Review and approve self-inspections performed by Wade operations and ensure appropriate actions are identified to address the observations. Ensure follow up of the action plan. Perform self-inspections of the department activities following the self-inspection planning, ensuring due date are respected. • Act as QA reviewer for procedures / ways of working. Be the QA representative in the Wade weekly SOP governance meeting an ensure the planning of review is realistic. Perform SOP / WOW QA review accordingly and ensure comments are discussed and implemented. • Support update/review of the department owned SOPs. • Coordinate monthly KPI meeting: extract data, prepare slides, align with stakeholders as needed. • Promote continuous improvement mindset in a day to day activities within the team and peers by using Operational Excellence tools (e.g.:IPO/PSS/Fishbone/5S…) • Participate in the management of team performances through regular shopfloor presence • Coordinate DRA (Distribution Risk Assessment) performance with relevant stakeholders, ensuring adherence to the plan. • Coordinate WDA (Warehouse Distribution Authorization) qualification process (i.e. pre-work with LOCs, WDA pre-assessment before upload to Veeva) • Collect inputs from relevant stakeholders to be shared with the auditing team for Audits to LOCs. • Rixthermo centralised mailbox: filtering, analysing mails received to prepare Tier meetings
Your profile ?
• 3-5 years of experience as QA in a pharmaceutical /biological production environment • Scientific background is required • Knowledge of Good Distribution Practices, including cold chain management. • Risk based approach methodology adept • Knowledge of regulatory, GMP, GDP and legal requirements relating to QA needed. • Good knowledge and expertise of quality systems, e.g. CAPA, Documentation Management, Training • Demonstrated capabilities in SAP • Fluency in French. Full level of English written and spoken • Good communication skills, proactiveness, independency, critical thinking and analysis of issues, impact and influence, innovative thinking, engage people, achieving excellence • Easy collaborative & networking capabilities • Agile mindset • Result-oriented – delivery on time • Team player
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]
Understand and translate Automation functional specification to process SME to ensure URS&TRS requirements are fully answered.
Strong background within manufacturing M&B(Media and Buffer) or USP or DSP process equipments
Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required, as well as mass balances.
Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
URS
Review the URS provided by the Engineering Office in order to ensure all User requirements are fully respected
Include all technical requests in the URS for the commissioning and qualification.
DETAILED DESIGNG
Review and participate in the technical specs and datasheets from Engineering Office
Review Functionnal specification for Automation from Engineering Office
Challenge technical solutions coming from Engineering office
Integrate safety, sustainability and green assessment in the design
Follow-up and challenges of the engineering office
Commissioning, Qualification&Validation
Perform Design review and Design Verification with the Engineering office and the CQV team
Lead and Participate to the FAT/SAT of Equipments in the scope
Support the qualification phases after commissioning (ASTM2500)
Organize quality checks on field before each technical milestone activiy.
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
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 schedulled and correctly organized/done
Are you the candidate we're looking for?
Master's degree
Minimum 15 years of experience within pharmaceutical companies and working with Engineering offices
Strong knowledge in Automation in PCS7
Good Knowledge of cGxP requirments
Manage a fluent communication between different stakeholders (Engineering office, User and others)
Good teamwork
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!
Project Engineering Lead Braine l’Alleud – Contracting Our partner is looking for a Project Engineering Lead to join its team. What are the responsibilities ? The Project Engineering Leader ensures projects are successful by taking full responsibility for: • Partnering with engineering firms to ensure proper support in delivering the project designs & execution. • Working with our Business Partner 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 technical resources identified without gaps nor overlap • Handling project governance, budget controlling in accordance with PMO requirements • Overseeing the project team supervision • Consolidating and reviewing specifications (e.g. URS, Technical Specifications) • Ensuring strong communication with stakeholders and team project • 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
Let's talk about you ! • ability to take initiative and work both independently and in a team environment • strong value commitment • experience in (complex) 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 technical, interpersonal and leadership skills. • able to translate customers’ needs in technical 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]
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
Are you the candidate we're looking for?
Master's degree
Minimum 5 to 10 years of engineering experience in project management
In-depth experience in a highly regulated environment
full professional proficiency in French and English (both oral and written)
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
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!