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Sterile Operator @ Thermo Fisher

Monza, Lombardy, ITOnsiteFull-time
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About this role

Work Schedule Other Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed Job Description

Join us at Thermo Fisher Scientific Inc. to excel as a Sterile Operator. This outstanding opportunity allows you to be part of an exceptionally ambitious team, contributing to world-class manufacturing operations in Monza. We are looking for individuals who can efficiently implement our high standards and thrive in a dynamic environment.

Specific Tasks/Primary Activities:

• Operate and clean production machines in the Injectable Department outside the Sterile Area according to the Batch Record and current SOPs. • Complete the Batch Record and departmental documentation related to the tasks performed. • Load filling lines outside the Sterile Area, ensuring material conformity as per the Batch Record. • Operate production machines in the Sterile Area according to the Batch Record and SOPs. • Perform filter integrity tests at the end of production activities as described in the Batch Record and SOPs. • Clean machines in the Sterile Area at the end of production activities following the Batch Record and SOPs. • Load/unload lyophilizers during production activities in compliance with SOPs. • Clean lyophilizer chambers as per SOPs. • Clean the Sterile Area at the end of production activities in accordance with SOPs. • Conduct daily checks to ensure the constant availability of materials for operating the Sterile Area. • Maintain machinery, materials, and the work environment, promptly reporting any anomalies to the supervisor. • Handle chemical and microbiological sampling activities, preparing the related documentation as required by SOPs.

Requirements and Qualifications:

Crucial:

• Education/Training: Middle School Diploma or equivalent experience. • Personality Traits: Responsibility, availability, and a proven track record in a similar role.

We value collaboration and dedication to flawless execution. If you are ready to take on new challenges and contribute to our mission, we want to hear from you!

Skills

good manufacturing practicessterile processingproduction machine operationbatch record documentationstandard operating proceduresfilter integrity testingchemical samplingmicrobiological samplingmaterial conformity verificationmachinery maintenancework environment safetydocumentation preparationsop complianceproduction line loading/unloadinganomaly reporting

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