Associate - Engineering & Computer System Validation

Eli Lilly and; Sesto Fiorentino; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A global healthcare leader is seeking a QA Associate for their Manufacturing Team in Sesto Fiorentino, Italy. The role involves ensuring that Automation Systems validation complies with GMP standards and supporting cross-functional teams in addressing non-conformances. Ideal candidates will possess a Scientific Master’s degree in Engineering or Chemistry, strong English skills, and knowledge of manufacturing computer systems. Join us in improving lives through healthcare innovation.

Competenze

• Previous experience in manufacturing activities is preferred.
• CSQA certification is a plus.

Mansioni

• Ensure alignment with GMP standards, granting Q oversight over Computer Systems.
• Approve the maintenance program and Validation deliverables.
• Guarantee oversight of team members' activities in Engineering.
• Cooperate in the investigation of deviation computer systems.
• Define maintenance and IT activities related to shut-down.

Conoscenze

Good knowledge of English (B2/C1 level)

Attitude to team working

Organizational and relational skills

Formazione

Scientific Master’s Degree (Engineering/Chemistry preferred)

Strumenti

Knowledge of manufacturing computer system

Knowledge of production processes and quality environment

Descrizione del lavoro

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Eli Lilly Italia is looking for a QA Associate - Engineering & Computer System Validation to join our Manufacturing Team in Sesto Fiorentino. He/She will be responsible of ensuring that Validation/Qualification of Automation Systems is compliant to the standards.

In addition to this, he/she will support cross-functional teams in investigating and addressing Computer Systems and Engineering/Utilities non conformances. He/she will also conduct problem solving and root cause analysis to address maintenance and computer system failures identified.

• Ensure alignment with GMP standards, granting Q oversight over the Computer Systems and Engineering
• Approve the maintenance program and Validation deliverables
• Guarantee oversight of the activities related to team members of Engineering
• Cooperate in the investigation of deviation computer system and maintenance related
• Guarantee the compliance of the activities of the department with respect to the quality related gap analysis
• Cooperate to the definition of maintenance and IT activities related to shut-down and return to service

• Scientific Master’s Degree (Engineering/Chemistry preferred)
• Good knowledge of English (B2/C1 level)
• Knowledge of manufacturing computer system
• Knowledge of production processes and quality environment
• Previous experience in manufacturing activities

• CSQA certification
• Attitude to team working
• Organizational and relational skills

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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