Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
Let's look together at your first challenge with us!
Project Start-up Lead
Scope of work:
Responsibilities and Objectives
Support to ensure the operational readiness for clinical and commercial production in multiple production sites in Flanders. In this role you are responsible for the development of operational processes in a safe and efficient way. You will also ensure that the operational requirements for the design of buildings, utilities, infrastructure, equipment and IT and production systems are included in the QMS taking the applicable EHS&S, compliance, and quality requirements into account. You will maintain focus on maintaining a strong culture of quality and continuous improvement and encouraging innovation necessary to meet project timelines and to improve process cycle times and production costs.
Tasks and Authorizations
You will help to deliver a fully operational process by supporting in diverse operational workstreams, e.g. aseptic cleanrooms, sterilization, gowning, systems & equipment, facility design, scheduling, material/sample/personnel/waste streams … including but not limited to the following responsibilities:
- Give operational input to develop the complete production process and the facilities, equipment and systems related to the process
- Project-based collaboration with all supporting departments (QA, EHS, QC, IT, Supply …) and process development teams to support the successful transfer of the process to GMP production facilities & the on-time delivery of clinical and commercial production
- Set-up and maintain partnerships with supporting departments and stakeholders to successfully transfer the operational process and meet compliance, quality and EHS&S standards
- Support the design and the implementation of manufacturing-related IT systems (MES, SAP…)
- Support the timely delivery of operational documentation and ensure a timely and qualitative roll-out of the training for the organization.
- Support the design of the (electronic) batch records – Actively support inspections
- Support setting up/providing input to Change Controls necessary for the preparation of the facilities
- Performing according to the cGMP, quality, compliance and EHS&S standards
In this way, you will contribute to a successful start-up of this product line in the EMEA region & you will obtain knowledge & expertise to grow to another function (e.g. Manufacturing Excellence, Quality, SC …) after the operational implementation.
Who are you?
- Master’s degree in a scientific or technical field (e.g. Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …) or equivalent in experience
- Pharmaceutical regulations (cGMP, GTP, 21 CFR 210/211, ICH, Eudralex Vol 4, ATMP, …)
- Experience in project management
- Experience in equipment/system qualification
- Experience in process design
- Start-up/can-do mentality, where you proactively search for solutions
- Be able to cope with a rapid changing environment
- See diversity as an asset
- Can handle procedures/guidelines which require strict execution
- Perfect speaking and writing skills in Dutch and English
- Knowledge of Trackwise, SAP and MES/EBR systems is a plus
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.