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!
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]
Prepare and plan technical assessments with the various stakeholders (technical experts, HSE, area managers, engineering and maintenance, external companies, etc.) and assure to cover all the scope of the project by ordering complementary studies if needed.
Manage the assessment teams (composed of External suppliers and the company's internal profiles) at different stages of the whole process.
Coordinate the third parties on the shopfloor.
Understand expert’s report; Translate in the company risks and remedial actions by taking the lead of risk analysis teams.
Identify the critical risks, and lead the different teams to take the immediate and conservatory actions (ex : safety of people, business continuity, …)
Support the internal processes of identification, evaluation and rising of the company risks.
Consolidate/Resume the conclusion of the assessment in a final report (Excel charts, Powerpoint presentation, resume, …)
Report the progress status of the technical assessment project (KPI, progress, success, issues, risks, etc.)
Consolidate and compile standards information’s for equipment as obsolescence, lifetime, amortization period, …
Review the process of technical assessment after each step by improving/adapting continuously the way of working.
Collect and sort the documentation and information necessary to establish the project files: offers, technical specifications, Analysis, technical documentation, HSE documentation, risk analysis, reports, rationalize the actions plans, etc.
Are you the candidate we're looking for?
Master's degree
Medior or Senior profile required – Min 8 years of experience
Experience within chemical, pharmaceutical or biotech company is required
Minimum Experience with People management (external/internal) & stakeholders influence
Fluent in French with competencies in writing/reading in English.
Technical Expertise is required
Expertise in cGMP and HSE standards
Excellent written and verbal communications skill
Synthetize complex technical problematics for non expert public
Ability to manage priorities
Ability to work independently and in a matrixial organization
Must a self-driver for his responsibility Ability to take initiative Be flexible and open to change
Ability to work by people influencing
Problem solving
Fundamentals in people management (incl change, decisions, conflicts, coaching, leading, etc…).
Customers’ needs focused
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!
Basically, there is a higher level planning part and a more operational part:
The person we're looking for will log on every morning and check their emails. If there are any emergencies, he/she will have to jump on them. Once this emergency has been dealt with, we'll have to see if he/she has any packaging to request, etc. So, operational activities.
Another activity: do I have any documents to update? If so, you'll have to take action.
Planning part: is my supply plan aligned with clinical needs or do I need to launch a reassessment? If so, I'll get in touch with the stakeholders.
Are you the candidate we're looking for?
Medior profile, 3-4 years of experience minimum (closed to less but not ideal and the profile must be very very good).
! Must have !
Organized.
Stress resistant.
Ability to switch from one activity to another.
Experience in supply is a must (with a pharma dimension if possible).
APICS certification: some knowledge of supply is essential.
-ENG mandatory.
Good communication skills.
Result oriented.
FR nice to have.
Experience in pharma is a BIG plus (it will influence our decision).
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!
The position is responsible for ensuring that key product data is maintained accurately, efficiently and effectively.
Master data operations:
Accountable for the complete product life cycle management:
o Manage and implement product launches: – Manage the Business Case once approved – Request the Finished Goods, Bulk and API codes in the MDM system – Analyze and determine the relevant product flows to be used for any new product code in order to allow the correct execution of the business process – Manage and coordinate the initial step in the collaborative workflow for code creation which will allow Forecasting and S&OP planning in OMP+ – Ensure correct master data set up in Supplying and Receiving plants in SAP o Manage the updates of non-printed components, bulk and API in the Bills of Material o Manage the product decommissioning – Launch and manage the deactivation of Finished Goods and ensure tracking and coordination of the activities to ensure deactivation and closure of Track Wise and QMS actions in line with agreed due dates.
Compliance responsibilities
o Change Controls: – Ensure correct stakeholder review based on Master Data Business processes and requirements – Ensure on time action, follow up and closure of action items o Deviations, Investigations and CAPAs – Perform investigations for deviations – On time action, follow up and closure of deviations, investigations and CAPAs
Project responsibilities:
o Contribute to projects with master data impact by providing master data and business process expertise and input Who are you?
Experience within the pharmaceutical industry and Supply chain knowledge
Knowledge of change control, deviation, etc.
Knowledge of SAP is a real plus
Fluency in English, French is an asset
Service minded with good written and verbal communication skills
System and process oriented with high analytical skills
Structured, detail minded and well organized
Assertive with good influencing skills
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.
This team has already started installing the equipment, so they are looking for someone to join the team.
What do we expect from you?
The installation concerns clean utilities (water loop, gas, etc.) and this team applies the oversight QA – qualification of the installations and then passes these qualified installations to the other teams :
Experience in installing clean utilities equipment
Ability to challenge partners on validation/qualification
Pass on to operations
Team info: 3-person team well integrated into the Genesis project structure.
Are you the candidate we're looking for?
Experienced profile preferred (minimum 5 years)
! Must have !
Experience in GMP clean utilities qualification (if other GMP production, we are ready to consider them).
Collaboration/team spirit
Ability to instill confidence (know how to get your ideas across without being pushy)
Stress resistant
Pharmaceutical experience is a must
Language: EN must have and FR nice to have
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!
Accountable/ responsible for ensuring the facilities is compliant with regulations and the standard quality systems in place, in collaboration with the owners of each individual area, which includes :
Access, confined areas and material and people flows through the facilities
Pest control management for the building (periodic visit and non conformity management)
Environmental monitoring (viable and non-viable) of the GMP areas and utilities, being the SPOC for the GMP manufacturing area and representative in the EM periodic meeting, managing asssessment of non conformities with stakeholders, suggesting actions and follow up with SMEs, reviewing/generating the periodic trending, keeping an eye on an optimal cleaning of the facilities.
Unexpected facility/environment event management (quick status, decision, quick actions plan and coordination with all the SMEs)
Risk management
Gowning process
Training of people on standard processes related to facilities and general quality systems
Highlight and prepare key topics and issues at Quality meetings
Quality standards/regulations Gap analysis, risk and remediation plans management
Monthly Quality Lead Team meeting preparation and Lead
GMP training annual refresh for the Pilot Plant: collaboration on the content
Deviations and Change Controls management linked to all the listed systems, general quality topics
Continuous improvement management linked to all the listed systems, general quality topics
Are you the candidate we're looking for?
Minimum Bachelor’s degree in sciences with min. 10 years experience in a regulated pharmaceutical area is required
Experience in production or quality, dealing with quality systems is required
Excellent understanding in GMP related environment
Experience with environmental monitoring is required
Experience in Biopharmaceutical is an asset
Experience dealing with Deviations and Change Controls
Foster lean and efficient processes, by continously challenging status-quo and striving for improvements
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 partner is currently looking for a Quality Ops Partner to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities?
You will be part of the Development Quality Pharma Operational team and will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development by :
Driving continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
Providing support to build the end to end “issued copy process’ for DEV/DSC entities.
Acting as Reconciler by checking the correct completion of the “issued Copy” process
Providing support during regulatory inspections, and quality improvement initiatives.
You will contribute the preparation of audits (internal/external, regulatory inspections)
Providing guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
Identify, mitigate and subsequently resolve compliance and quality issues that may affect internal development activities and products.
Supporting QA activities for all Dev QA entities ( Lab, pilot plant,…..)
Maintaining and continuously improving Quality systems and processes in place for the appropriate documentation of internal development activities and ensure compliance with regulatory and corporate requirements.
Implementing and maintaining adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
Managing Quality meetings to maintain adequate level of compliance of the business activities.
Ensuring data integrity and compliance with regulatory requirements and industry best practices
Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems (deviation close out / change management/ complaints/ quality improvement).
Ensuring Development Quality Management System directly support Technical Operations and development partner goals and objectives.
Who are you?
You hold a master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
Good written/oral communication in English
Ability to work autonomously for the assigned activities with limited supervision
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations.
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.
Vendor Quality Lead Contracting – Walloon Brabant Our partner is currently looking for a Vendor Quality Lead Drug Product to join its team. This international company is well-known for its pharmaceuticals. What are your responsibilities?
Being the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors.
Performing the QA review of deviation notifications and change controls, retrieving and collecting supportive information from involved stakeholders to allow assessment.
Managing the key performance indicators for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance
Ensuring all Quality agreements are in place and take ownership of agreements for the vendors. Maintaining Quality Agreement with the vendors up to date and performing periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, being sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensuring the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensuring that this review is documented and made available in the Controlled Documents System.
Participating as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Monitor and trend vendor performance including tracking of CAPA events and closure
Quality Complaints: Being the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensuring that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed, working with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinating vendor quality related investigations
Participating on ad-hoc basis to the Product Change Control Committees for activities related to the vendors and review change controls as QA stakeholder.
Providing expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Working closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Covering the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Owning of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensuring all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensuring review of relevant RA dossier section related to the assigned vendors
Having the overview of audit and HA inspections related to the vendors. Tracking and following-up on Audit observation and CAPA plan implementation at the vendor.
Being the QA stakeholder for Vendor Risk management.
Managing and controlling quality documents related to the vendors in the Controlled Documents System
Providing support to customer audits and Health Authority inspections at the vendors, as needed
Receiving, coordinating, reviewing and authorizing product reworks and repackaging
Being the point of contact for post-release vendor quality issues (supply chain, distribution, etc.)
Who are you?
You hold a Master’s degree in scientific domain.
You have an experience within the pharmaceutical industry and in a Quality Assurance role.
You are familiar with aseptic processes.
You have an experience in root cause and risk management/assessment skills.
You have an experience in CMO management.
Knowledge of validation is a plus.
You are knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
You have good background knowledge of the pharmaceutical industry from a business and technical perspective.
You are able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
You speak fluently French and English.
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.
