CSV
ENGINEER

We are seeking a CSV Engineer with proven experience to manage validation deliverables for complex computerized systems in highly regulated environments. This position is ideal for candidates with 3-5 years of experience that works independently with clients and ensures 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.