Senior CSV Engineer – Brussels, Belgium – 6+-Months Contract - Hybrid
Are you a CSV Engineer and are interested in working with one of the leading companies in the pharmaceutical industry? Join a hard working team of Engineers and gain valuable experience working on an project in Brussels, Belgium.
Role Overview:
Lead, execute, and supervise CSV activities for pharmacovigilance systems. Act as a deputy for the IT Compliance Lead and coach for junior resources and stakeholders.
Title: Qualification Engineer
Location: Brussels, Belgium (Hybrid)
Positions Available: 1
Type: Contract (6+-Months)
This role is available immediately, contact us now!
Your Responsibilities:
* Lead and execute validation activities and deliverables for assigned changes and projects.
* Identify validation approach and deliverable list.
* Author and review CSV deliverables, including Validation Requirement Assessment, Validation Plan and Report, Test Protocols and Reports, and Traceability Matrix.
* Monitor deliverable sequencing and completion.
* Manage end-to-end validation documentation and testing activities.
* Coordinate test execution with IT system owners, business owners, and testing teams.
* Create test protocols and reports (IQ/OQ/PQ/MQ).
* Support test script writing and execution with IT and business stakeholders.
* Manage Deviations and related actions (investigations, CAPA).
* Escalate issues or delays to the IT Compliance Lead.
* Be available and committed during Inspection/Audit preparation and defense.
* Act as deputy for the IT Compliance Lead and share validation status with the project team.
* Report personal activities through weekly meetings.
* Participate in weekly activity review meetings.
* Coach junior CSV resources and other stakeholders on CSV and compliance activities.
Your Requirements:
* Minimum 8 years of experience in CSV projects.
* Strong communication, negotiation, and stakeholder management skills.
* Proactive, dynamic, and hands-on with the ability to work autonomously.
* Strong analytical and problem-solving abilities.
* Ability to prioritize tasks in a fast-paced operational environment.
* Proficient in English and French or Dutch.
* GPVP (e.g., Argus, ArisG, Veeva Safety)
* GCP (e.g., Clinical Trial Monitoring systems)
* Veeva knowledge is a plus.
If you are interested in this role, please do not hesitate to send me your CV today for an immediate response!
mbernhard@optimussearch.com