Vision systems project engineer

ThermoFisher Scientific; Monza; In loco; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific in Italy is seeking a qualified engineer to support the vision systems MS&T Team for the automatic inspection of sterile injectable medicines. The role focuses on introducing new processes and optimizing existing ones, ensuring GMP compliance and alignment with regulatory expectations.

You will develop validation and qualification documents, create and refine inspection recipes for new and existing products, and provide technical troubleshooting to enable smooth

Competenze

• Bachelor's degree in Engineering or related scientific field.
• Experience in pharmaceutical/validation is advantageous.
• Experience with automated inspection systems is helpful.
• Proficient in English (written and spoken).
• IT skills: Trackwise, Minitab and Microsoft Office.
• Excellent interpersonal skills and teamwork.

Mansioni

• Support vision systems MS&T Team in introducing new processes and optimizing existing ones for automatic inspection of sterile injectable medicines.
• Issue validation documents and strategies for setup and qualification according to procedures and GMP guidance.
• Develop inspection recipes for new products and optimize existing recipes.
• Provide technical expertise and troubleshooting to support operational activities.
• Participate in project teams discussing technical aspects of new product introduction strategies for regulatory submission.

Conoscenze

English

Teamwork

Troubleshooting

IT knowledge

Formazione

Engineering degree

Strumenti

Trackwise

Minitab

Microsoft Office

Körber

Optrel

Innoscan

SEA Vision

Descrizione del lavoro

Work Schedule

Flex 12 hr shift/days

Environmental Conditions

Office

Job Description

Purpose of the position/responsibility:

Support the vision systems MS&T Team in ensuring the introduction of new process, and the optimization of the existing one, related to the automatic inspection of sterile injectable medicines, managed through technical documents, in compliance with current regulations (GMP standards, FDA, Ema etc.)

Specific tasks/primary activities:

Technical and validation documents: Issuing documents relating to the automatic inspection systems that must be validated, in order to define the strategy necessary for the setup and the qualifications activities of automatic inspection systems, in compliance with the company procedures and guidance.

Develop inspection recipes for new products and implement optimizations on existing recipes utilized for commercial products.

Support the effective execution of operational activities by providing technical expertise and troubleshooting assistance.

Participate in the project teams discussing technical aspects of the new product introduction strategy to be submitted to the regulatory authorities.

Requirements and qualifications

• Degree in Engineering or similar scientific degrees or consolidated experience;
• Previous experience in pharmaceutical companies or validation is helpful;
• Previous experience with automated inspection systems (Körber, Optrel, Innoscan, SEA Vision or similar) is helpful;
• Proficient English (both written and spoken);
• IT knowledge: Company IT systems (Trackwise, Minitab) and Microsoft Office tools;
• Personal skills: Excellent interpersonal skills, proactivity, ability to work in a team.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.