CSV & DI Squad Lead

Posted 3 days 1 hour ago by Panda International

Permanent
Not Specified
Other
Antwerpen, Belgium
Job Description

Vacancy: Squad Lead - Computer System Validation (CSV) & Data Integrity (DI)

Location: Geel region, Belgium

On-site presence: Minimum 80% required

Employment type: Contract / Project-based


About the Role

We are currently seeking an experienced Squad Lead for Computer System Validation (CSV) and Data Integrity (DI) for a leading pharmaceutical manufacturing site in the Geel region. In this role, you will co-lead, alongside local process owners, the alignment of existing CSV and DI practices with current industry standards. A strong focus will be placed on risk-based methodologies, regulatory compliance, and sustainable implementation of best practices within a GMP-regulated environment.


Key Responsibilities

  • Provide direction on CSV & DI best practices, applying science-based, risk management approaches
  • Oversee multiple ongoing projects and manage both internal and external resources (contractors)
  • Ensure the quality and regulatory compliance of project deliverables, in close collaboration with QA
  • Drive change management initiatives to ensure long-term adoption of improved processes
  • Mentor and coach the Local Process Owner (LPO) to elevate knowledge and adherence to industry standards


Your Profile

  • Strong expertise and hands-on experience with CSV and data integrity in a pharmaceutical manufacturing environment
  • Preferably experienced in an API setting, with knowledge of DeltaV, PI, PCS7, and alarm management best practices
  • In-depth knowledge of FDA and EMA expectations on CSV and DI, with practical experience using risk-based validation approaches and documentation
  • Excellent project management skills, including planning, organizing, and coordinating
  • Demonstrated ability to lead teams in complex and fast-paced environments
  • Skilled in coaching, change management, and training
  • Able to navigate across multiple organizational levels and influence without direct authority
  • Language requirements: English (required), Dutch (preferred)


What's Offered

  • A strategic and high-impact role within a global pharmaceutical environment
  • Dynamic and multidisciplinary project work
  • Competitive compensation (freelance or fixed-term contract possible, depending on your profile)
  • Opportunity to make a lasting contribution to compliance, quality, and innovation


Interested or want to learn more?

Please get in touch or send your CV to .