Engineering & Validation Project Manager – Exothera

“Exothera is a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. 

Exothera is a rapidly growing, dynamic, young organization, part of the Univercells Group. We operate in an environment where every person counts and teamwork is key to our success. It means that each employee has an opportunity to shine, to be a part of a culture that values enthusiasm, innovation, and problem-solving while supporting our customers through the challenging world of bioprocessing and manufacturing. 

Apply and be part of this great adventure!

Mission

Based in Jumet, as Engineering & validation Project Manager, you will be responsible for the engineering and validation of multiple projects  linked to upgrade and modification of our facilities on Exothera sites. You will in charge of all the aspect of the project, form the project definition, until the completion and validation. 

Operationally you will report directly to the Head of Technical Services.

RESPONSIBILITIES

  • Be the engineering single point of contact for engineering subjects linked to upgrade or modification of our facilities in Jumet and Gosselies.
    • At the beginning of the project, assess the need of the projects and define the URB with the user
    • Realize the Design and budget definition 
    • Follow the procurement phase and select the supplier needed
    • Follow the construction and the commissioning
    • Follow all the GMP process (from the URS to the IQ/OQ)
  • Strong support of Maintenance, and Manufacturing teams during start-up, PQ & ramp-up phases.
  • Supervise, manage, train & coach engineers and technicians, internal and external partners, and all stakeholders (for engineering & validation topics/practices).
  • You will manage contractors working on the project and will be the garant of the quality of their work 
  • Ensuring that the project is in line with the planning and budget is your responsibility. You will regularly monitor work in progress, approve the financial milestones and report on the status of each assignment
  • You will coordinate with all project-related personnel on day-to-day progress of work activities, procurement and operations to ensure timely completion of the project

REQUIREMENTS / QUALIFICATIONS

  • Master degree in Engineering and proven technical knowledge in Electricity & automation, HVAC, clean utilities.
  • 5 to 10Y experience, with minimum 2 years of successful and relevant experience in biotech GMP activities (Viral Vectors for Cell & Gene Therapy, Viral Vaccines, Vaccines) 
  • Experience in multidisciplinary projects within matrix organizations.
  • Demonstrated capacity to effectively manage and execute projects from initiation to completion.
  • Excellent communication and organization skills with an ability to communicate effectively with all levels inside and outside the organization
  • Execution/adherence – demonstrated record of on time delivery
  • Excellent analytical and organizational skills, pragmatism, and positive critical thinking.
  • Resilience and agility in demanding environment.
  • Right First Time & Customer-oriented.
  • Fluent in French and English