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Software Validation and Compliance Engineer

2 mesi fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Description

As a key member of the Thermo Fisher Scientific team, you will play a critical role in ensuring the compliance of our information systems with Italian, European, and American guidelines. Your expertise in software validation and compliance will be instrumental in shaping the future of our company.

Main Responsibilities:

  1. Execute validation projects under the supervision of a CSV specialist.
  2. Edit validation documents, including specification documents, risk analysis, and validation protocols, in accordance with site procedures.
  3. Collaborate with other site functions and external contractors to complete validation tasks while adhering to internal and external guidelines.
  4. Ensure that validation documents from suppliers and contractors meet quality standards.
  5. Apply local and global procedures to ensure the implementation of company policies.
  6. Collaborate with internal areas, including manufacturing, maintenance, QA/QC, logistics, and IT, to ensure seamless integration.

Requirements:

  1. Computer Science or Scientific degree or equivalent.
  2. GMP/GAMP knowledge.
  3. Proficiency in Word, Excel, and MS Project.
  4. Previous experience in information systems validation is an asset.

At Thermo Fisher Scientific, we value diversity, equity, and inclusion. Our employees are our greatest asset, and we strive to create an environment where everyone can thrive. We are committed to accelerating research, driving innovation, and supporting patients in need.