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]
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 Global Quality Lead 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?
This position provides support to a Global Quality Lead relative to Quality Assurance activities associated with the lifecycle management for a product transitioning from Development to Commercial by:
Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.
Maintenance and lifecycle management of QA product flows
Audits and Inspection anticipation and readiness
Review of Annual Stability Plan
SOPs and other control documents writing, review and approval as needed
Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
Who are you ?
You already worked in GMP environment for 5 years
You are experienced in operating across cultures and in a multi-cultural environment
You have experience in GMP audits and inspections would be an advantage
You are Fluent in French and your English is not bad
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.
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!
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!
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!
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!