CSV Specialist

Company Description

For over 30 years, Lesaffre has been involved in Human Health & Nutrition as part of its ambition to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech and officially combined it with Lesaffre Human Care to form a new Business Unit named Gnosis by Lesaffre.

At Gnosis by Lesaffre, we are committed to cultivating and to delivering nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing, thanks to the power of microorganisms and biotransformation processes like fermentation. Put differently, we explore life to improve living.

Our vision: At Gnosis by Lesaffre, we strive for a world that moves better, digests better, ages better, feels better, and, ultimately, lives better thanks to microorganisms and biotransformation.

Job Description

As the CSV (Computer System Validation) Specialist you will report directly to the CSV Manager and be the subject matter expert responsible for running CSV activities in Gnosis BU.

Main responsibilities:

• Championing full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GMP regulation and computer system validation (CSV) guidance.
• Support the periodic review of software applications used in GMP processes, including those for quality control, production, and supply chain.
• Collaborate with cross-functional departments (QA, IT, Production, QC) to ensure that systems are compliant and fit for purpose.
• Prepare, review, and maintain validation documentation: URS, FRS, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Summary Reports.
• Support the change control process, assessing the validation impact of changes to GMP systems.
• Act as a subject matter expert (SME) during audits and inspections, providing documentation and evidence related to system validation and compliance.
• Working with system vendors to leverage appropriate information and documentation into CSV activities.
• Coordinate and oversee the activities of external consultants involved in CSV projects.
• Working with process owners to identify and implement new systems and upgrade existing systems to aid improvements to compliance and reduce risks to patient safety, product quality and data integrity.
• Provide first-line support and training to end-users on GMP-relevant applications, ensuring proper use and adherence to procedures.
• In collaboration with the IT Dept. act as system administrator for local GMP-relevant applications e.g. Laboratory systems, eQMS.

Qualifications

• 3–5 years of experience in a CSV role within a GMP-regulated pharmaceutical environment. Experience in API manufacturing is a plus.
• Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or a related field.
• Knowledge of GAMP 5, PIC/S guidance, and general validation principles.
• Strong understanding of FDA, EU and other governing bodies regulations and requirements for GMP including FDA 21 CFR Part 11, EU Annex 11.
• Knowledge of data integrity and data governance (ALCOA+ principles)
• Good understanding of client-server architecture, databases (e.g., Oracle, SQL Server), and network concepts
• Proficiency with Windows Server and Windows OS environments
• Knowledge of typical GMP software (e.g. ERP. MES. LIMS, CDS, Laboratory Systems)
• Good documentation and communication skills.
• Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams, including QA, IT, and external vendors
• Strong analytical and problem-solving mindset.
• Professional working proficiency in English

Additional Information

• The job is based in Desio (MB) - Italy
• Full-time contract
• Possible Smart-Working after trial period
• Be part of a growing company
• Work in a dynamic international environment
• We are a successful family-owned company with long-standing history where people truly matter. 
• We promote a sense of fulfilment with a genuine mission: nourish and protect the planet. 
• An opportunity to work in a real international environment. 

At Lesaffre, diversity is a strength that enriches our culture and our teams. We are committed to offering you a work environment where you can thrive, regardless of your background, gender, age or abilities. We encourage all applications, as we believe that diverse perspectives strengthen our ability to innovate and meet the challenges of tomorrow.