Overview
We are seeking an IT Computer System Validation Engineer to support the validation of software systems. This role is crucial for ensuring compliance with global regulatory requirements in a dynamic environment.
Responsibilities
* Support the planning, coordination, and execution of validation activities for software systems.
* Development of validation documentation, including requirements, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation reports.
* Collaborate with cross-functional teams to ensure validation activities align with compliance needs.
* Coordinate with Quality Lead to ensure adherence to EU GMP Annex 11, FDA requirements, and relevant ISO standards.
* Interact with colleagues and documentation in the Italian language.
* Act as the point of contact for validation-related queries.
Qualifications
* Proven experience in software validation engineering.
* Strong knowledge of EU GMP, FDA 21 CFR Part 11, and ISO standards.
* Ability to develop comprehensive validation documentation.
* Fluency in Italian and English, both written and spoken.
* Strong communication and collaboration skills.
Nice to Have
* Experience with validation in the pharmaceutical or biomedical industries.
* Familiarity with risk management techniques.
Other Details
* This position is onsite in Italy, with two locations available: Medolla and Grosotto. The role is set to start immediately.
Job Details
* Seniority level: Entry level
* Employment type: Full-time
* Job function: Information Technology
* Industries: IT Services and IT Consulting
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