Validation Specialist

Lesaffre Iberica SA; Modena; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading company in Health & Nutrition is looking for a technical specialist to perform qualification activities of production machines and controlled environments. The role includes drafting and reviewing protocols, ensuring compliance with GMP standards, and collaborating with teams on validation processes. Ideal candidates will have a Master’s degree and a solid understanding of cGMP, along with proficiency in English.

Competenze

• Master's degree in technical or scientific fields is essential.
• Good knowledge of current Good Manufacturing Practices (cGMP) is required.
• Proficient in English, both written and spoken.

Mansioni

• Perform qualification activities (IQ/OQ/PQ) for production machines and utilities.
• Draft and review qualification protocols for GMP equipment.
• Assist in change control activities related to qualifications.

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.) of areas with controlled contamination, 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

1. Perform, directly or with external support, qualification activities (IQ / OQ / PQ and Final Qualification Reports) of plants, machines, utilities, and controlled contamination environments according to planning;
2. Draft and review qualification protocols for GMP equipment;
3. Assist in drafting URS and S.A.T. / F.A.T.;
4. Collaborate with relevant personnel to evaluate and complete activities required by change control related to qualifications, ensuring compliance with procedures and deadlines;
5. 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 dedicated to Human Health & Nutrition, aiming to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech, integrating it with Lesaffre Human Care to create Gnosis by Lesaffre. We are committed to developing nutritional actives, probiotics, and functional yeasts that enhance human health and wellbeing through microorganisms and biotransformation processes like fermentation. Our vision is to foster a world that moves better, digests better, ages better, feels better, and lives better through microorganisms and biotransformation.

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