Validation Specialist

Execution of all activities related to qualification and periodic requalification of production machines, utilities (e.g., HVAC, PRW, Compressed Air, Nitrogen, etc.) of the 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

• Perform, directly or with support from 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;
• Collaborate in drafting URS and S.A.T. / F.A.T.;
• Work 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 subjects;
• 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 ambition to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech and integrated it with Lesaffre Human Care to create 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 like fermentation. We explore life to improve living. Our vision: At Gnosis by Lesaffre, we aim for a world that moves better, digests better, ages better, feels better, and lives better through the power of microorganisms and biotransformation.

J-18808-Ljbffr