IT & CSV Senior Specialist

Celyad Oncology is looking for anIT & CSV Senior Specialist. The successful candidate will be

based in Belgium and will report into the IT Director in Mont-Saint-Guibert.

Role & Responsibilities

Role:

Job purpose is to participate to the creation and implementation of an IT team and organization
within Celyad Oncology. The scope of this position is to set up, manage, maintain and
troubleshoot technology systems, software, computers, servers and networks.
He/She will also advise and support the company’s business on standard IT aspects and
qualification requirements in a GxP regulated environment.

Responsibilities:

• Review diagnostics and assess the functionality and efficiency of systems/network

• Implement IT security measures

• Monitor security certificates and company compliance with requirements

• Offer technical support to company staff and troubleshoot computer problems

• Install and update company software and hardware as needed

• Anticipate and report the cost of replacing or updating computer items

• Manage IT Service and Software providers

• Administrate collaborative and offices tools

• Accountable on IT hardware and software asset management

• Participate to internal and external IT audits

• Train end users on IT procedures and security measures
• Write and update IT procedures

• Participate in Computerized System Validation(s) activities, such as User Requirements

writing, Validation strategies, IT Systems verifications

• Management of relationships with stakeholders

• Responsible for Celyad IT infrastructure, more specifically manage day to day qualification

• Participate in IT vendor qualification and validation package assessment
• Follow up vendor activities from IT perspective
• Attend project meetings as IT Expert
• Participate in IT system(s) risk assessments
• Support system(s) change management from IT perspective

Qualifications & Experience

• Education: Master’s degree in computer science / Engineering degree or other relevant

• Minimum 5 to 7 years working experience in similar roles
• Min 3 years’ experience in Biotech or Pharma industry
• Experience in setting up :

o Relevant operating systems as windows server
o Data Base system as SQL Server
o VMware ESX
o Collaborative tools as Zoom, Teams, Slack, SharePoint…
o Security tools

• Working knowledge on website development and security / WordPress
• Understanding of regulatory requirements:
  

o GMP, GxP (GCP, GLP are a plus)
o EudraLex Volume 4, Annex 11 and Annex 15
o FDA 21 CFR Part 11
o Data Integrity requirements
o GDPR

• Experience with Quality Management Systems

Skills & Competencies

• Strong interaction & communication skills
• Team player, cross functional capabilities
• Autonomous & proactive
• Good project management and organizational skills
• Excellent problem-solving and critical thinking skills
• Keen attention to details
• Good writing skills

• Can do attitude and Hands-on approach
• Eager to work in a regulated environment (pharmaceuticals)
• Strong work ethic
• Languages: fluency in English and good level of French (oral and written)

For more information about this position or about the Company, please contact us by email at
job@celyad.com

About Celyad Oncology
Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and
development of chimeric antigen receptor T cell (CAR T) therapies for cancer. The Company is
developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy
candidates for the treatment of both hematological malignancies and solid tumors. Celyad
Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY.
The Company has received funding from the Walloon Region (Belgium) to support the
advancement of its CAR T cell therapy programs. For more information, please visit