Project Lead Site Start-up

il y a 2 semaines

Beerse, Flandre, Belgique Pauwels Consulting Temps plein

Job description:

  • For one of our biggest clients we are looking for a Project Startup Lead to help start their new site in

Gent. This person will need a very strong pharmaceutical expertise.

This Project Lead will have 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 CAR-T process to GMP production facilities & the on-time delivery of clinical and commercial production

  • Setup and maintain partnerships with supporting departments and the Legend Biotech organization to successfully transfer the operational process and meet compliance, quality and EHS&S standards
-
Support the design and the implementation of MAKE IT systems (MES, SAP, EMS, IDP, Vineti...)

  • Support the timely delivery of operational documentation (SOP's, WI's, FORM's, protocols) and ensure a timely and qualitative rollout 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 CAR-T in the EMEA region & you will obtain knowledge & expertise to grow to another function (e.g. Manufacturing Excellence, Quality, SC) after the operational implementation

Benefits:

  • Uitdagende projecten in lijn met jouw interesses en talenten
  • Persoonlijke opvolging en open communicatie zowel voor als na indiensttreding
  • Mogelijkheid tot het volgen van extra opleidingen
  • Inspirerende netwerkevents en legendarische afterwork drinks
  • Sterk netwerk van toonaangevende klanten
  • Expertise binnen IT, Engineering en Life Sciences
  • Een vliegende start voor elke junior, verdere groei en kennisdeling voor onze seniors

Have you got what it takes?:

  • To fulfill the Project STart-up Lead role in

Gent you will need to meet the following requirements:

Knowledge:

-
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
  • Startup/cando 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

Education:

-
Master's degree in a scientific or technical field (e.g. Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry)

Languages:

  • English
  • Dutch

It is also a big plus if you have experience with the following systems (but not a requirement as they can be learned on the job):

  • Trackwise
  • SAP
  • MES/EBR systems
Reference number: 55185

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