Validation Specialist

Lesaffre Iberica SA; Venezia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading company in the health and nutrition industry seeks a professional for qualification and requalification activities of production machines and utilities in compliance with Good Manufacturing Practices. The position demands technical expertise and a master's degree, offering an opportunity to work at the intersection of technology and healthcare.

Competenze

• Master's degree in a relevant field.
• Good knowledge of cGMP.
• Proficiency in written and spoken English.

Mansioni

• Perform qualification activities (IQ/OQ/PQ) of production equipment.
• Draft and review qualification protocols for GMP equipment.
• Coordinate change control activities to ensure compliance.

Conoscenze

Knowledge of cGMP

Proficiency in English

Formazione

Master’s degree in technical or scientific fields

Descrizione del lavoro

Execution of all activities related to qualification and periodic requalification of production machines, utilities (e.g., HVAC, PRW, Compressed Air, Nitrogen, etc.), laboratory equipment, and the validation of related computer systems (CSV) in compliance with Good Manufacturing Standards, national and international regulations, and company policies.

MAIN RESPONSIBILITIES

• Perform, either directly or with the support of external personnel, qualification activities (IQ / OQ / PQ and Final Qualification Reports) of plants, machines, utilities, and controlled contamination environments in accordance with planning;
• Draft and review qualification protocols for GMP equipment;
• Assist in drafting URS and S.A.T. / F.A.T.;
• Coordinate with relevant personnel to evaluate and complete activities required by change control related to qualifications, ensuring compliance with procedures and timelines;
• Assist in drafting and updating SOPs related to the management and validation of equipment, utilities, and controlled contamination areas.

QUALIFICATIONS

• Master’s degree in technical or scientific fields;
• Good knowledge of cGMP;
• Proficiency in written and spoken English.

Company Description

For over 30 years, Lesaffre has been involved in Human Health & Nutrition as part of its mission to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech and integrated it with Lesaffre Human Care to form Gnosis by Lesaffre. We are dedicated to developing and delivering nutritional actives, probiotics, and functional yeasts that promote human health and wellbeing, leveraging microorganisms and biotransformation processes such as fermentation. Our vision is to create a world that moves better, digests better, ages better, feels better, and lives better through the power of microorganisms and biotransformation.

J-18808-Ljbffr