Construction Safety Coordinator – Senior The mission The construction EHS coordinator shall be a competent construction professional, responsible for checking that the project construction activities are executed safely in accordance with the company’s requirements. What are the responsibilities? • coordinate construction activities and liaise with the Host Site EHS team • review safe methods of working ahead of work starting • lead daily safe work planning sessions e.g. SPA, RAMS, PTW • participate in daily prestart workforce safety briefings • participate in safety meetings and lead daily safety walks of the site • participate in toolbox talks • assist in incident investigation • induct / orientate the workers • identify and control new workers • identify general and specific safety hazards to the workers • inspect and conduct safety audits of tasks and safe systems / processes • ensure that all incidents are reported • participate in incident investigations • ensure workers only carry out tasks for which they are trained and qualified • ensure risk assessments and method statements are in place and in use • encourage and participate in the behavioural safety system • intervene and correct any unsafe conditions • participate in safety meetings • ensure good housekeeping and organised tidiness (5S) at all times
Experience and Knowledge requirement • Experince in construction management of medium and large capital projects • EHS experience Soft Skills: • Project and people management skills with thorough knowledge of construction • Communication and collaboration skills
Education, Methodology & Certification Requirements; • University or college training in engineering or EHS • Formal safety professional certification
ICT Skills (software, operating systems, hardware, etc.); MS Office
Language Proficiency Requirements: English – Business French – Fluent
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]
CSV EXPERT Contracting – Braine l’Alleud The mission: New MES projects for both manufacturing & Lab’s scope – the goal is to support the activities creation of Test script in Opcenter or XFP and MES for Siemens and to support the validation of IT applications in the labs (Empower, LIMS, ELN). The focus is on Manufacturing (MES) like Siemens Opcenter, but there is a potential evolution to Laboratory and Industrial. The mission includes Test creation, execution monitoring and GMP/GDP projects.
What are the responsibilities? • Create, Test script and review execution in QALM • Creation of all documents in SourceCD based on the Source CD procedures and on the validation approach (deliverable list) approved by a UCB IT Compliance Lead • Support Medior/Senior to Review project test execution review in QALM • Create / Update IT Validation template
Experience and Knowledge requirement Must-haves: • Minimum 3 to 5 years of experience • Experience required in CSV, GAMP5, with a minimum of 1.5-3 Years of experience in CSV • Fluent in English
Nice-to-haves: • QALM • LIMS, Empower, ELN • French is a big plus (business is French-speaking)
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]
Industrial Lead Analytical (ILA) Associate The scope of the position is global within the entire Supply & Technical Solutions (S&TS) network of the Company. The role is focused on supporting, from an operational and project execution standpoint, the Analytical Industrial Lead of commercial products, from late phase development (for commercial readiness) to the end of the life cycle of products. What are the responsibilities? • Providing support and expertise to specific projects led by your team or stakeholders (e.g. implementation of a new regulations, coordination of stability studies to support a process change, support submission readiness for various geographies …) • Implementing analytical life cycle plans or integrated analytical solutions through project management • Being responsible for one or more cross-products activities or business processes (in full or a part of it) within the remit of your department • Supporting ILAs for operational activities within the remit of the department. • Connect with people to develop and maintain interfaces with operations (e.g. QC laboratories, CMO, CLO) • Use your project management skills to implement decisions, plans and solutions • Show-off your energy and dynamism to evolve in a complex matrix environment • Work in autonomy with a problem solving & pragmatic mindset. • Work on several projects in parallel with agility and smooth communication to support members of the team
Experience and Knowledge requirement • Proven project management skills including planning, monitoring, issue resolution, risk mitigation and reporting • Exposure to GMP, Regulatory Affairs and Quality applied to analytical • Fluent in English and French • Customer and results oriented • Ability to summarize challenges and issues to management • Knowledge of basic Microsoft tools (Teams, Excel, powerpoint,..) • Ability to review data and documentation with a scientific eye • Knowledge of pharmacopeias and Physchem methods 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]
Our partner is looking for a Computer System Validation to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Writing, reviewing and approving of validation plans and validation summary reports
Reviewing and approving of Technical Change Description
Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, …
Reviewing of CVS specific SOP’S and Templates
Ensure the proper execution of the qualification and validation activities with respect of the company validation methodology
Who are you ?
University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
You speak French and English
Certification in computer system validation or equivalent is a plus.
Experience in a computer systems validation role
CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
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 mission New MES projects for both manufacturing & Labs scope – the goal is to support the activities creation of Test script in Opcenter or XFP and MES for Siemens and to support the validation of IT applications in the labs (Empower, LIMS, ELN)
Day-to-day activities • Create, Test script and review execution in QALM • Creation of all documents in SourceCD based on the Source CD procedures and on the validation approach (deliverable list) approved by a the IT Compliance Lead • Support Medior/Senior to Review project test execution review in QALM • Create / Update IT Validation template
Profile Must-haves: – Experience required – CSV, GAMP5 a minimum of 1.5-3 Years of experience in CSV – English
Nice-to-haves: – QALM – LIMS, Empower, ELN – French is a big plus (business is French-speaking)
Minimum number of years of experience: 3-5 years
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 Project Manager – Business Support to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Design the project organizational structure and assigns responsibilities. Ensure team members are completing their tasks according to plan.
Contribute to the development of the RFP strategy definition
Support and ensure that local teams are collecting RFP requirements according to plan.
Manages risks on the project through periodic identification with the team and stakeholders, prioritization and manages the countermeasures and/ or mitigation.
Foster relationships between Vaccines and Medicines global teams (Procurement, Engineering, QA, EHS..) and local Engineering/Procurement teams from 6 countries.
Support Global Procurement during the supplier selection process (meeting schedules, action log, minutes of minute, technical and commercial clarification, decision criteria, sourcing approval).
Carries out performance management on the project, escalating issues in a timely manner and reports monthly
Design and deliver solutions and processes in support of project objectives and requirements.
Ensure the overall project plan, timeline, risks and issues are being managed effectively by the teams.
Ensure that the knowledge base (information and people) is developed and maintained, ensuring effective transition of knowledge into the support organisation.
Ensure holistic communications planning ansd stakeholder management approach is in place and active with each site.
Ensure that training needs are identified, defined and delivered accordingly
Participate and support project steering meetings Review outsourcing strategy
Deploy FM contracts, and oversee the transition, mobilization and stabilization phases of the contract deployment with the implementation of monitoring tool, business continuity plan and exit plan
Who are you ?
Ability to work in French and English
Master in Engineering or Business
At least 8-10 years in industrial projects (engineering, maintenance)
Experience in Operation Excellence including Maintenance Excellence
Good knowledge of the international Facility Management market
Knowledge in Procurement process and contract management
Skills in Perfomance Management (LEAN culture, Continuous Improvement)
Proven track record in project management, including global RFPs
Know-how of engineering activities within the pharmaceutical industry
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.
Analytical Methods Validation Bio About our client The new Global Quality (GQC&PQ) organization have the goal to bring innovation, integrated capabilities, and speed to our customers through an empowered team that deliver results and enable network success. Within GQCPQ, the Global Quality & innovation team drives Transversal Innovation through multi-sites feasibility, POC & implementation of new technologies for QC Project is to support the feasibility, fit-for-purpose and business cases of new immunoassays replacing current in-vivo potency for DTaP vaccines. The missions 1. To develop, design, perform & analyse new immunoassays (ELISA, Luminex) (Primary skill). 2. Manage the feasibility & fit-for purpose study including, project management, business case and reporting & communication to different stakeholders (Secondary skill) Primary Tasks & Responsibilities
Manage the feasibility & fit-for-purpose of new immunoassays.
Perform experimental plan, analyse the results, manage the troubleshooting.
Manage lab work (training, stock management, data integrity); Work in GMP lab environment.
Feasibility, fit-for-purpose, and method development design.
Demonstrated proficiency one or more of the following areas:
Immunoassay development, validation (for QC)
Project management
Lab activities
Data analytics (including calculation method)
Preferably minimum 3 years’ experience in the Pharmaceutical Industry with proven lab activities management of and project management
Capability of working independently and ability to prioritize tasks and meet strict deadlines.
Knowledge
The activity requires a broad and thorough knowledge of immunoassays including development, validation and method troubleshooting.
Strong interest and experience in immunoassay and scientific software development
Experience in software use (SoftMaxPro, Combistat, PLA, Gen5,…)
Soft Skills: · Strong problem-solving skills, profound background in scientific analytical method · S/he will be well organized, open-minded, able to work on different projects in parallel, and have a project-orientated spirit. · S/he should have good communication skills in English and an open, proactive personality to work in a team of young international researchers.
Excel or other soft for data analysis (tab, graph, basic statistic) Familiar with MS Office package
Language Proficiency Requirements · English Fluent · 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]
It is imperative to have used these techniques in an analytical environment.
Are you the candidate we're looking for?
Bachelor's or Master's degree in Analytical Biochemistry
Knowledge of liquid chromatography, size exclusion, etc.
Fluent in English
MUST HAVE:
Laboratory skills
Substantial experience in at least one of the above techniques
NICE TO HAVE:
Understanding of GMP + strong communication skills
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!
Ensuring quality for the validation part in the relevant projects (e.g., PUPSIT, RTU, …)
Conducting QA Oversight of validation activities
Actively participating in defining validation strategies in collaboration with project/validation teams and in compliance with GS requirements
Reviewing and approving all documentation related to validation (URSFMEA-LRA-CRA-DQ-IOQ-PQ-Leveraging Reports)
Participating in deviation investigations and troubleshooting
Key responsibilities:
Reviewing and approving all documentation related to the projects under their responsibility: validation plans, validation summary reports, URS, FMEA, Leveraging Reports, IQOQ protocols and reports, PQ protocols and reports, CRA, LRA
Actively participating in the project and process design phase to understand the project and establish an appropriate implementation and validation strategy
Establishing workload planning based on project schedules
Ensuring the chronological and logical execution of validation activities
Actively participating in project follow-up meetings, troubleshooting, and addressing various issues to anticipate validation impacts or risks and contribute to developing solutions
Ensuring QA Oversight of implemented methods
Providing coaching/transferring/handover of knowledge related to different projects
Your profile ?
Engineer or university degree in biotechnology, agronomy, chemistry, pharmacy, etc.
Minimum of 5 years of experience in an aseptic laboratory/industry, quality, or production environment
Experience in a regulated environment such as cGMP
Experience in industry validation; and in specific documents: URS, FMEA, Leveraging Reports, LRA (L=Leachables), CRA (C=Compatibility)
Knowledge of IPV (In-Process Verification) and PA (Proces Analytical Technology) processes is a plus
Advanced knowledge of aseptic technologies, closed systems
Experience as a QA Validation professional
Knowledge of GMP and aseptic environments
Our offer ?
We offer you a permanent contract and an attractive salary package. You'll also benefit from the opportunity to develop personally and professionally through in-house training. If you're interested, don't wait any longer!
Support the overall Warehouse and Distribution Excellence (WADE) management team to succesfuly transfer its activities to new facilities.
The focus will mainly be on supporting our Warehouse Manager Operations and our Global Performance System (GPS) Lead in their daily activities in order to enable them to focus on the activites related to the new facilities.
Main activities:
Operations
Responsible for securing and role modelling a safe and healthy environment as per company's standards
Manage raw materials and vaccines shipments to internal and external customers as per applicable regulations
Ensure compliance of operational activities with GXP, quality, training, EHS and security requirements.
Provide support to compliance activities (CAPA/Deviation management, training coordination, L1 audits, etc.)
Participate to the relevant governances, meetings workshops where needed
Escalate to the Wade leadership team any issue not allowing a smooth management of the above items.
Continuous Improvement
Manage the deployment of continuous improvement initiatives in accordance with our GPS master plan
Manage the orchestration of our project portfolio, including project prioritization and progress monitoring
Support the operational team in implementing an effective performance management system
Participation to the relevant governances, meetings workshops where needed
Escalate to the Wade leadership team any issue not allowing a smooth management of the above items.
Your profile ?
Bachelor degree or equivalent
Min. 5 years experience in manufacturing/distribution within the vaccines industry (i.e. ideally in Logistics)
Strong continuous improvement background
Strong project management background
Fluency in French and English
Excellent communication skills
Proven agility/adaptability to changing environment
Our offer ?
We offer you a permanent contract and an attractive salary package. You'll also benefit from the opportunity to develop personally and professionally through in-house training. If you're interested, don't wait any longer!
