Software Validation Engineer
A unique opportunity to work in a greenfield manufacturing site and grow your career with a global leader in the medical device industry.
Responsibilities
* Manage the validation and operational management of computerized systems.
* Create and review validation documentation according to regulatory requirements and divisional policies.
* Develop Software Compliance assessments, such as 21 CFR Part 11 and Data Integrity.
* Maintain the quality and compliance status of associated Procedures and Work Instructions.
* Present and communicate status reports, identify trends, potential issues, and improvement initiatives.
Qualifications and Experience
* Bachelor's degree in IT, Engineering, Manufacturing, or Science preferred.
* Working knowledge of software validation in medical devices or pharmaceutical validations.
* Experience working in a 21CFR and/or ISO regulated industry desired.