| Location | Beerse, Belgium |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 25089 |
| Published | 1 day ago |
Location: Geel region, Belgium
On-site presence: Minimum 80% required
Employment type: Contract / Project-based
Duration: 6 Months + option for renewal
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.
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
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)
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.