General information
Publication date
25 / 07 / 2025
Category
OPERATIONS - ENGINEERING / PRODUCTION
Job title
Quality Engineer - IT Compliance - Pharma
Contract
Permanent contract
Job description
Akkodis is a global leader in engineering and research & development, aiming to accelerate innovation and digital transformation through connected data.
With a passion for technology and talent, the group comprises over 40,000 engineers and digital experts, generating a turnover of 4 billion euros, offering extensive cross-sector experience across 28 countries in North America, EMEA, and APAC.
The Life Sciences division of Akkodis is a leading engineering consultancy in Italy, specializing in validation and GMP services for pharmaceutical, chemical, and healthcare companies. Composed of highly skilled consultants with proven expertise in Good Manufacturing Practices, collaborating with major international companies to ensure compliance with FDA and European standards. Services include Engineering, Commissioning & Qualification, IT compliance, Process & Quality, Advanced therapies, Training, and GxP.
To strengthen our division, we are looking for a:
Quality Engineer - IT Compliance - Pharma
Join our Life Sciences division, which includes over 400 consultants in Italy and approximately 5,000 across Europe. Our strength lies in integrating diverse expertise to provide a comprehensive view of the pharmaceutical industry.
Your contribution at Akkodis
Within our IT Compliance team, you will participate in a project to revamp laboratory QC systems at the client's site.
The project involves migrating laboratory instrumentation connected to the IT infrastructure to the OT infrastructure within the manufacturing domain.
The main activities include:
* Review of documentation and specifications
* Risk assessment related to migration
* Updating URS
* Validation protocols creation and execution
* Preparation of addenda for requalification
* Final report issuance
* Updating/emission of administration SOPs
Business Industry
Life sciences
Profile
Degree in a scientific field, preferably in Computer Engineering, Chemical Engineering, or Industrial Chemistry, with at least 2 years of experience in CSV within pharmaceutical environments.
You will join the IT Compliance team within the Life Sciences division, working on projects involving different software technologies and engaging with high-level industrial environments.
About you
Requirements to start your professional journey:
* Experience in validation of computerized systems such as ERP, LIMS, and QMS
* GMP knowledge
* Understanding of FDA CFR 21 Part 11 / EU Annex 11 regulations
* Knowledge of GAMP5 guidelines
* Excellent skills in MS Office (Word and Excel)
* Experience in validation of control systems for industrial automation (PLC, SCADA, DCS) is a plus
* Basic IT concepts familiarity
* Good command of written and spoken English (at least B2 level)
* Willingness to travel
Offer
Permanent contract
What you will find at Akkodis
* A structured and personalized career path with opportunities for vertical and lateral growth
* Access to a Corporate Benefits Platform
Location
Terni and Rieti with up to 20% remote work possible
Job location
Europe, Italy, Lazio
Locations
Rieti and Terni
Candidate criteria
Minimum education level: Master’s Degree
Experience: 1 to 3 years
Key Skills
Dhcp, Active Directory, VMware, Computer Networking, PowerShell, Microsoft Windows Server, Windows, Microsoft Exchange, SAN, Azure, Operating Systems, Dns
Employment Type : Full-Time
Experience : 1-3 years
Vacancy : 1
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