JOB DESCRIPTION
* Job Summary: We are seeking a Software Validation Engineer to support the validation of software systems at our Client's Hechingen facility. The ideal candidate will work with German speaking local site personnel and global software validation engineering team to ensure that systems comply with global regulatory requirements (such as EU GMP, FDA 21 CFR Part 11).
* Key Responsibilities:
* Support the planning, coordination, and execution of validation activities for Hechingen site software systems.
* Support the 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 project timelines and compliance needs.
* Work with Quality Lead to ensure alignment with EU GMP Annex 11, FDA requirements, and relevant ISO standards.
* Work with German speaking colleagues and German documentation
* Act as the point of contact for validation-related queries.