Overview
Ellab Italy, in Pero - Milan, is looking for a senior CSV & Compliance professional to lead validation projects for computerized systems in GxP-regulated environments. The role involves defining validation strategies, coordinating cross-functional teams, and supporting clients in achieving full compliance with international standards (GAMP 5, 21 CFR Part 11, Annex 11).
What you will be doing in this role?
With a strong focus on digital transformation and data integrity, you’ll drive innovation in validation processes while ensuring quality, efficiency, and regulatory alignment.
- Define and oversee validation strategies for clients
- Coordinate CSV consultant teams and support training of junior resources
- Ensure quality and compliance of all deliverables
- Support regulatory inspections and client audits
- Drive innovation in validation processes through digital and paperless solutions
Skills and experience
We are looking for a service minded colleague with a passion for improving quality processes with a keep it simple mindset. You have excellent collaboration skills and are self-driven, proactive, positive with a can-do attitude. You are a strong and natural communicator verbal as well as written and your work approach is structured and systematic.
Technical and Regulatory Expertise
- In-depth knowledge of international regulations and standards, including GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and ISO 9001
- Solid experience in the validation of computerized systems: ERP, LIMS, MES, SCADA, laboratory and manufacturing systems
- Strong command of the full CSV lifecycle: VMP, URS, FS, HDS, IQ, OQ, PQ, Risk Assessment, Change Control
- Ability to conduct audits, gap analyses, and compliance assessments in GMP-regulated environments
- Deep understanding of data integrity principles and electronic document management
Preferred Software Skills
- Ability to develop and customize software in regulated environments
- Hands-on knowledge of:
- VB.NET
- VBA
- SQL
- PowerApps
- Experience integrating digital solutions to manage and automate CSV processes
Cross-Functional and Managerial Skills
- Operational and strategic leadership of multidisciplinary teams and complex projects
- Strong client orientation with ability to understand needs and propose tailored solutions
- Effective communication with both technical and managerial stakeholders
- Advanced problem-solving skills, especially in regulated and high-compliance environments
- Project planning and multitasking capabilities, ensuring deadlines and budgets are met
Education and Experience
- Degree in a scientific or engineering discipline (e.g. Computer Science, Biomedical Engineering, Chemistry, Pharmacy)
- 7–10 years of proven experience in CSV, preferably in consulting firms or GMP-regulated industries
- Excellent command of written and spoken technical English
Commercial and Business Development Skills
- Ability to identify business opportunities and propose targeted consulting services
- Experience in client management and relationship building
- Aptitude for developing new projects in competitive markets
- Collaboration with the sales team to prepare technical and financial proposals
What we offer
- Opportunity to work in a global, dynamic and fast-paced environment
- Opportunity to influence your own tasks/responsibilities and develop your career in a supportive environment, making a real impact on a growing international company
- You’ll be joining a team highly focused on execution and optimization, while also recognising the importance of work-life balance.
The hiring process
If you find this opportunity exciting, apply today! We will review the applications as they come in and the interviews will be conducted ongoing.
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📌 CSV & IT Compliance Manager
🏢 Ellab
📍 Losine