Automation Specialist

Work Schedule

Standard (Mon‑Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Thermo Fisher Scientific seeks a standout individual in Monza to join our Engineering team.

Main Responsibilities

• Work together on projects to introduce new equipment and SCADA systems (iFix, Rockwell Automation, Siemens), ensuring consistent methods and meeting necessary standards for accurate operation in the manufacturing zone according to rules and company quality guidelines.
• Assist the Engineering team with the integration of new equipment and control systems, guaranteeing a flawless process.
• Furnish the required criteria for the accurate application of computerized systems in the manufacturing sector, in accordance with regulations and quality standards.
• Assist internal functions with computer systems management (e.g., Rockwell Automation systems, IMA Line, stand‑alone systems).
• Lead variations/modifications concerning GMP computer systems/data integrity, aiding in the execution of CAPA/changes.
• Apply documentation management tools (e.g., TrackWise, D2 - Documentum).
• Develop risk assessment for GMP computer systems and their data control.
• Develop SOPs concerning data management/system access for the manufacturing sector.
• Establish SOPs for software/data management of GMP Computer systems.

Proficiencies

• Degrees in Computer Science or related fields or equivalent experience.
• Knowledge of GMP/GAMP and computer systems validation guidelines.
• Proficiency in Word, Excel, MS Project.
• Previous experience in information systems validation.

Hybrid site/remote work offered.

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