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 s.canelas@panda-int.com .