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]
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]
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]
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.
The Vx Capital Investment team manages different portfolios of CAPEX projects in Belgium and Global Operations. The Capital Investment Definition and Start-up team is responsible to ensure all CAPEX projects definition phases and start-up phases are delivered according to plan with Safety & Quality standards as a priority. The team is also accountable for the adherence to the company engineering standards and practices in the projects. The project then goes in Execution, either in CAPEX Primary, CAPEX Secondary, CAPEX Tranversal or CAPEX Automation depending of the type of project. The position of Project Scheduler, critical to enabling the successful delivery of the pool of Projects and to manage the resources capacities, must be filled. The Project Scheduler reports to the Project Controller / Project Manager with the role continuing through end of Detail Design and Building Commissioning and Qualification.
Develop a project schedule to be implemented for the various phases of the Project life cycle with different detail level depending on the phase of the project (master schedule to level 4 schedule)
Challenge schedule provided by contractor (Engineering Office)
Regularly monitor progress against the project schedule and report any discrepancies to the Project Manager.
Participate in independent schedule reviews and incorporate findings
Participate in the risk management and analysis exercise and assess schedule impact of identified risks
Carry out schedule analysis to identify critical path and optimisation of same
Facilitate interactive planning for integrated schedule development
Ensure that all members of the Project Team are kept fully aware of the status of project schedules by reporting on progress, especially at key milestones
Extract critical path
Integrate the company schedule and contractor schedule in one integrated schedule
Participate in gate review
Play the role of scheduling tools (MSP, MSP online…) expert inside the Team and are the referent.
Provide support to the Project Managers part of the Team
Develop and regularly update the Project schedules for all the projects part of the Vx Project Management Team by collaborating closely with the different project managers to ensure that all monthly (project) reports are done in due time and in compliance with PMO the company standards.
Comply with the reporting requirements in place such as but not limited to, recurrent MS Project Online updates and project status updates.
Consolidate and extract the company resources workload forecast considering current projects from the company scheduling tools.
Extract key milestones for governance or Project Stage Gates by project/portfolio in order to allow the Team to anticipate the associated efforts and to increase the chance of success
Collaborate closely with the company PMO Teams
Liaise with other Project Team members and external contracting bodies as necessary to ensure the smooth flow of relevant information required for scheduling purposes.
Develop and maintain planning tools and documents in compliance with the company Project Management Framework.
Fill MSP Online reporting
To ensure that all activities within this responsibility are undertaken on time to allow the smooth progression throughout the Project from Initiation to Hand-over
Are you the candidate we're looking for?
Minimum Bachelor’s degree
Robust experience with planning with large, multi-level, international projects
Background in the pharmaceutical industry is a plus
CAPEX Project management experience as scheduler
PMP certification is a plus
Robust experience with preparation of presentation for senior management
Stakeholder management & influencing skills
Prior knowledge of the company standards & systems is a plus
Proven CAPEX project delivery experience within the company is a plus Soft Skills
Strong leadership skills & proven team management
Organizational 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 partner is looking for a Construction Manager to join its team. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
To have overall responsibility for monitoring and organizing the construction and demolition activities associated with the Project.
To ensure that a comprehensive Construction and Demolition Plan is prepared and updated, which co-ordinates all Project construction and demolition activities.
To provide the management resource, as appropriate, throughout the construction and demolition phases to ensure co-ordination of activities and achievement of agreed milestones.
To ensure designers, contractors and other team members are EHS competent and appropriately prequalified • To ensure that the Manager of the Construction (contractors) delivers the project safely in conformance with the local regulations and in compliance with the company requirements
To agree the responsibilities and accountabilities for project construction EHS with the host site EHS Manager
To encourage and support an EHS culture that supports the values of the company
To write the initial Construction Safety Plan (CSP) for briefing the Manager of Construction (contractors)
To ensure all workers receive a host site and project specific construction induction
To ensure that the CSP is regularly reviewed and updated by the Manager of Construction
To implement a process of EHS performance assurance through a programme of audits, observations and interactions
To ensure that the Manager of the Construction (contractors) implements a proactive EHS programme encouraging recognition of the workforce and feedback / engagement with the workforce
Your profile?
Degree in Engineering or Sciences
Experience in a similar function
BA5 certificate
Pharmaceutical experience is an asset
PM experience
PM certification is an asset
Rigor in execution, results driven; Demonstrated strength in problem solving
Analytical skills and demonstrated ability to influence
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.
