CSV
ENGINEER

We are seeking a CSV Engineer with proven experience to manage validation deliverables for complex computerized systems in highly regulated environments. You will work independently with clients and ensure full compliance with GAMP 5, Annex 11, and 21 CFR Part 11.

 

Responsibilities:

• Lead and execute qualification activities (FAT, SAT, IQ, OQ, PQ) for standalone and networked computerized systems;


• Draft and review System Configuration and system lifecycle documentation;


• Develop Computer System Validation Plans and Validation Reports;


• Drive Risk Assessment activities (RA, Data Integrity, Process Mapping);


• Write and revise SOPs related to CSV and Data Integrity;


• Collaborate directly with client stakeholders (Engineering, QA, IT, Production);


• Review Functional Specifications (FS), Hardware Design Specifications (HDS), Software Design Specifications (SDS), and Configuration Specifications (CS) provided by suppliers or system developers;


• Ensure alignment between user requirements, system design, and validation deliverables.

 

Requirements:

• Bachelor’s or Master’s degree in Engineering or scientific fields is required;


• 3-5 years of hands‑on experience in Computer System Validation within pharmaceutical, biotech, or other GxP‑regulated industries;


• Solid knowledge of GAMP 5 and Data Integrity principles;


• Proficiency in Microsoft Office;


• Availability to travel nationwide based on project requirements.

 

Language Requirements:

Because this role is based at an Italian client site, candidates must meet the following criteria:

• Fluent Italian (mandatory)


• Good English knowledge (written and spoken)

Note: Applications from candidates who do not speak Italian cannot be considered.

 

What We Offer:

• Competitive compensation based on experience;


• Meal voucher / client’s canteen;


• A company car is available for client‑site travel and can be picked up from our headquarters in Sabaudia (LT);


• Smart working authorized by the company for CSV activities suitable for remote execution;


• Continuous professional development and long-term career progression;


• Exposure to top-tier industry clients and innovative technologies;