CSV Engineer

CAI; Bologna; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A professional services company is seeking a Computer Systems Validation Engineer to support GxP validation in regulated environments. Responsibilities include developing protocols, writing documentation, and ensuring compliance in a GMP environment. The ideal candidate will have experience in biotech or pharma, strong communication skills, and a BS in a relevant field. This full-time position is based in Bologna, Italy.

Competenze

• 2-7 years' experience with Computer Systems Validation.
• 2 years' experience working in a GMP environment.
• Experience in biotech and pharma preferred.

Mansioni

• Develop and execute protocols and test scripts.
• Write GxP computer validation and 21 CFR Part 11 documentation.
• Identify gaps and develop resolution plans.

Conoscenze

Computer Systems Validation

Data Integrity with GAMP

Excellent communication skills in English

Formazione

BS in Computer Science or Engineering

Strumenti

MES

Delta V

PI

Descrizione del lavoro

Overview

CAI is a professional services company established in 1996 that serves Life Sciences and Mission Critical industries with optimized operational readiness and performance. This description reflects a Computer Systems Validation (CSV) Engineer role focused on GxP validation in regulated environments.

Key Responsibilities

• The CSV Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.

Position Requirements

• BS in a Computer Science or Engineering field or equivalent experience
• 2-7 Years’ Experience With Computer Systems Validation
• 2 years’ experience working in a GMP environment
• Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired
• Experience in biotech and pharma is preferred over medical device
• Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
• Other Requirements: Excellent oral and written communication skills in English/Fluent in English
• Able To Travel Domestically And Internationally As Required
• La selezione rispetta il principio delle pari opportunità (l. 903/77)

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Engineering and Information Technology
• Pharmaceutical Manufacturing

Location: Metropolitan City of Bologna, Emilia-Romagna, Italy