CSV Engineer

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique Optimus Life Sciences Temps plein

CSV Engineer - Brussels, Belgium - 6+ Month Contract - Hybrid

I am currently looking for an experienced CSV Engineer who is interested in working for one of the leading companies in the Biopharmaceutical sector. This is a fantastic opportunity to join a hard-working team and work on an exciting project in the biotech sector.

Title: CSV Engineer

Location: Brussels, Belgium (2 days a weeks onsite)

Positions Available: 1

Type: Contract (6+ Months)

If you think your skills and experience are suitable for this position, please do not hesitate to contact me

Responsibilities:

  • Validate and deliver assigned Changes and Projects.
  • Define validation approach and deliverables with the IT Compliance Lead.
  • Author and facilitate CSV documents (Validation Plan, Test Protocols, Traceability Matrix).
  • Manage deliverable sequencing, monitoring, and documentation.
  • Coordinate test execution with IT system owner, Business Owner, and testing team.
  • Create and support test protocols and reports (IQ/OQ/PQ/MQ).
  • Manage Deviations and related actions (CAPA, investigations).
  • Escalate issues or delays to the IT Compliance Lead.
  • Assist during Inspection/Audit preparations.
  • Act as deputy for the IT Compliance Lead on assigned projects.
  • Report activities in weekly meetings with the IT Compliance Lead.

Requirements:

  • University degree/diploma with 3+ years of relevant experience.
  • Experience in global teams and autonomous work.
  • 3+ years in CSV Projects.
  • Strong communication, negotiation, and stakeholder management skills.
  • Proficient in English; French is a plus.
  • Manufacturing (PCS, SCADA, MES) e.g., Siemens PCS7/XFP, Emerson DeltaV/Syncade.
  • Laboratory systems (LIMS, ELN, CDS) e.g., Labware, Empower Waters.
  • Experience with GMP, GDP, and/or GLP projects.

If you are interested in this role, please do not hesitate to send me your CV today for an immediate response

mbernhard@optimussearch.com

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