CSV IT Quality Expert for Cell Therapy

Bristol-Myers Squibb Co; Leiden; On-site; EUR 75,000 - 110,000; Full time

Job summary

Bristol Myers Squibb Co. seeks a Senior Specialist for IT Quality and Computerized Systems Validation in Leiden.

You will provide hands‑on CSV/IT compliance support for the Cell Therapy Facility, acting as SME on CSV matters and aiding audit readiness and regulatory responses. Responsibilities include developing validation documentation, reviewing qualification testing, and collaborating with operations to ensure compliant, validated systems across GMP environments.

Qualifications

• Bachelor’s in engineering, IT, Science field or equivalent.
• Minimum 3+ years of relevant industry experience.
• Prior Cell Therapy experience is highly valued but not required.
• Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
• Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including MES, LIMS, QMS, ERP, Process Automation, Historians and Benchtop systems in QC and MFG.

Responsibilities

• Provide hands‑on support for CSV activities, projects, deviations, and change controls related to computerized systems.
• Act as CSV SME for changes and IT/Automation projects, providing input to operations on CSV matters and supporting audits.
• Contribute to standardized qualification testing documents and related deviation documentation.
• Review and approve qualification documents as part of CSV activities and support pre/post‑approval testing.
• Support regulatory audits as a Digital Plant representative with CSV and IT compliance input.

Skills

CSV SME

IT Quality

GxP knowledge

Regulatory compliance

Audit support

Education

Bachelor’s in engineering or IT

Tools

MES

LIMS

QMS

ERP

Historians

Job description

Bristol Myers Squibb Co. seeks a Senior Specialist for IT Quality and Computerized Systems Validation in Leiden.

You will provide hands‑on CSV/IT compliance support for the Cell Therapy Facility, acting as SME on CSV matters and aiding audit readiness and regulatory responses. Responsibilities include developing validation documentation, reviewing qualification testing, and collaborating with operations to ensure compliant, validated systems across GMP environments.