The Responsibilities • Is accountable of the design and execution of his projects – mainly in management of some different projects/program (multiple/interaction management of dashboard, status advancement and health for each project/program). • Coordinate and manage activities with partner (engineering company) during projects design & execution (all portfolio of projects/program will be produced with Engineering company). • Coordinate all technical activities and planning for execution of a project. • Have a larger understanding of all related disciplines to challenge/review globally and identify potential issues. • Have a relevant or previous experience in Pharma (rules GXP, GMP or GLP) and have expertise in Intregrate (Planisware SW) Infrastructure, Security or Annex 01 is a must. • Is also person of reference of overall project activities – cost, schedule, quality, risk mgmt, Gate mgnt,… • Project point of contact with management, business clients, external or engineering companies and technical team. • Alignment with global standards – technical, green, safety, GMP, … • 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.
Skills and Knowledge Requirements • 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. • 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]
Our partner is looking for a Process Workstream Lead to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
TECHNICAL SKILLS
Lead the engineering process team and act as the spoc for all process equipment from design until the handover after verification. Organize his/her team to address to address the best engineering good practice and collaborate with key users.
He/She is in the driver seat, with a full management of supplier, User, QA, EHS, C&V team and will be measure with the success of process equipment implementation.
Strong background within manufacturing USP & DSP (upstream & downstream) bioprocess equipment (Single use systems: bioreactors, UF/DF filtration skids, Chromatography skids, ATF, Mixer), Fill and finish, autoclave and washer.
Expert of single use equipment and aseptic used
Strong knowledge on GEP and global engineering standards.
Ability to Lead P&ID and PFD setup is required, as well as mass balances, FS, HSD, SDS,…
Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
Knowledge and expertise in verification ASTM E2500
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
Capable to benchmark with peers in the industry and able to identify latest trends
Excellent communication skills in order to present frequent reports to Management.
BASIC & DETAILED DESIGN
Define the applicable standards/norms/engineering guidelines for the project
Provide Engineering offices with the applicable standards
Challenge technical solutions coming from Engineering office
Integrate safety, sustainability and green assessment in the design
Define List of Delivrables for his discipline
Provide project delivrables of his discipline to Engineering Leader
Follow-up on progress/ ETC.
CONSTRUCTION
Based on progress report of the construction manager, perform on a regular basis field spot check follow-up
Organize quality checks on field before each technical milestone activiy.
Communicate the day to day schedule (planning level 4) to the Engineering Leader and construction manager
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
Define battery limit and RACI matrix with Engineering Leader
Update drawings in its area of expertise
Write commissioning documentation and ensure that the supplier's documentation is acceptable to perform verification (ASTM 2500)
Perform FAT/SAT activities in its area of expertise
Support the qualification phases after commissioning (V-Cycle and/or ASTM2500)
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 scheduled and correctly organized/done
Who are you ?
Master's Degree
Minimum 10 years of experience within pharmaceutical companies and working on CAPEX large projects.
Dynamic person with strong value commitment & resilient Strong Process Technical expertise
Fluent in English is mandatory. French is highly desirable.
Good Knowledge of cGxP requirements
GEP – Good engineering practice expertise
Excellent communication skills (able to present to Management, Engineering office, User and others) and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
Team player, Rigorous, Accountable, Involved, Proactive.
Pragmatic to solve issues; solution oriented with a positive mindset
Autonomous, fully acting at own's initiative.
Broad 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.
Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Able to both take direction and mentor other team members
Able to translate customers’ needs in technical requirements
Open to travel to support UCB strategic international projects
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.
Our client Contracting – Braine L’alleud Our client is looking for a Portfolio Manager to join their team for a global project. About the role This job is a key role under the Portfolio & Project Management Organization within Global Engineering and Facilities. Its goal is to secure visibility on the Global Physical Asset Management’s (GPAM) portfolio including resources, timelines, costs, risks and compliance of our projects with Project Management guidance enabling informed decisions. GPAM is a global organization ting research, development, manufacturing, and commercial activities. This scope is mainly focused on Belgian, Swiss, UK, and US sites. It supports local asset owners in taking the right decisions while monitoring their risk level. The portfolio manager will facilitate a portfolio or six (6) clusters and a budget about twelve (12) million euros. Since the organization was founded in June 2022, a portfolio management approach is not fully implemented. This position reports to the Project Performance & Capacity Management Lead. Your responsibilities Project Methodology Control and escalation • Ensure compliance with GPAM’s project management guidance • Support the Project Excellence department to develop new project management methodologies withing GPAM • Support to the standardization of project methodologies with global and local PMOs • Financial control of projects • Ensure Project landing are updated regularly Portfolio Capacity Management and resource utilization • User of global engineering capacity management system used to foresee GEF’s resource requirements, bottlenecks, risks and support the implementation of appropriate actions to meet objectives • Ensure data quality and compliance to process & tools with internal and external stakeholders • Supports resource allocation discussion with GPAM’s, Investment Strategy and Early Design and Strategy team and PPMO team Project & Departmental Metrics • Further Develop, produce, and maintain the KPIs of GPAM in collaboration with all relevant teams • Contribute to harmonization within GEF’s different departments Project Risks/Issues/ Key learnings Management • Consolidate, analyze, and report key risks/issues for GPAM’s portfolio • Consolidate and follow the different projects mitigation Project Scope & Deliverable Management • Ensure appropriate tracking and Control of change of scope, deliverables • Escalate to relevant team/PMO deviation Support continuous improvements of project processes/tools/governance within PPMO • Develop tools, and processes to make available best practice and key learnings, house of knowledge development PMO services • Ensure PMO support/ support gating process / Appropriation request in areas not covered by a PMO (ex: Automation, HS&E) • PPMO primary point of contact for GPAM Knowledge and experience requirements • At least a bachelor’s degree in a relevant field • Certification: PMP or PfMP (PMI)or Prince2 [Mandatory], Green Belt (Lean) • At least five (5) years of experience in portfolio management and its implementation with a certification • Having a first experience in leading portfolio change in a company 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 Senior validation engineer to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities. Write and coordinate approval of change controls related to technical modifications.
Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
Establish and monitor validation KPIs.
Review handover of equipment / systems from suppliers and or other project stakeholders.
Who are you ?
More than 5 years of experience with PQ phase having led and managed validation projects, including sterile manufacturing.
Must have experience of working on projects; project management experience. We need someone who understands and knows what to do but not a PM expert.
Knowledge of safety, GMP and environmental regulatory requirements.
Expert in reviewing and writing technical reports.
EN is a must have
Ability to work with other persons – team spirit.
Homeworking : authorized, but must remain flexible according to project needs.
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.
R&D clinical Contracting – Braine l’Alleud Our client is looking for a profile to fill a position in R&D clinical development. The role involves clinical studies in F1 and F2.
What are the responsibilities? • Activities related to the design, and everything related to the analytical development. • Taking the lead on protocols studies
Experience and Knowledge requirement • Proven project management skills • Experience in medical monitor for vaccines studies • Degree or background in the medical field or proven experience • Nice to have: clinical method development plan management • Fully fluent in English both written and spoken
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]
Sites and Infrastructures Partner Our client is looking for a Sites and infrastructure Partner to join its team. The role Sites and infrastructure Business Engineering Partners serve as the central point of contact and a robust bridge connecting the Business area, Engineering, and Project Leaders for various facilities infrastructure aspects (such as buildings, roads, parking, landscaping….). The role includes:
Strategic Perspective: Consolidate the overall technical perspective of thebusiness area.
Budget and Feasibility: Accountable for delivering feasibility and design studies.within the budget for the 10-year plan.
CAPEX Coordination
Engineering Support: Sites and infrastructure Business Engineering Partnerscoach and mentor Engineering Managers, ensuring strong technical deliverables forCAPEX Projects.
Resource Allocation
What are the responsibilities?
Understanding Customer Needs:
Gather and comprehend requirements from customers.
Assist customers in articulating their needs to create a GP0 (General
Proposal).
Scenario Development:
Think creatively and prepare various scenarios.
Present these scenarios to stakeholders.
Project Initiation (GP0 Approval)
Support the Sponsor or Idea Owner in launching the project.
Collaborate with the Technical Engineering Team to identify the Project
Leader (PL) and establish the team structure for GP1 (Detailed Proposal).
Drive the project toward achieving GP1.
Coach the Project Leader on following the methodology.
Participate in Project Steering Committee (SteerCo) meetings.
Connecting Customers and Global Engineering:
Serve as the liaison between customers and the Global Engineering
structure.
Communicate customer requests to the engineering team.
Assist the engineering team in resource allocation, technology planning, and
high-level resource needs.
Relay project-related issues from Engineering to customers (Global
information).
Monitor and facilitate the handover process.
Experience and Knowledge requirement
Minimum 5 years in Infrastructure projects like Project Leader or Team Manager
Minimum 1 years within chemical, pharmaceutical or biotech company with minimum technical background (process and utilities).
People management with a minimum of 2 years in a Production/engineering environment as supervisor or manager.
Project management with a minimum of 5 capital projects succefully delivered and experience in capital project management up to min 10 mioEUR.
Experience in risk management (and related specific tools (FMEA, HAZOP)
Experience in capital and asset management is an asset.
Experience in Masterplan building
Fully fluent in English and French
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]
