Software Validation Engineer - Medical Devices

Key Responsibilities:

Execute validation plans and protocols for R&D projects affecting facilities, equipment, processes, cleaning, and software systems.

Perform qualification of equipment such as ovens, sterilizers, HPLC/UPLC systems, molding machines, refrigerators, and freezers.

Conduct temperature mapping and environmental monitoring of critical systems.

Lead cleaning validation and utility qualification efforts.

Write and review validation documentation, including URS, FS, IQ, OQ, PQ, TM, validation plans, and summary reports.

Maintain and track validation status for multiple platforms and projects.

Assist in prioritizing R&D validation activities and reviewing SOPs related to validated systems.

Troubleshoot complex equipment/system issues with a risk-based approach to validation.

Develop re-validation protocols and manage deviations and reports.

Collaborate cross-functionally with Engineering, QA, IT, and Production teams.

Ensure validation requirements are aligned with technical change controls.

Preferred Qualifications:

Experience in validation within the pharmaceutical or medical device industry.

Familiarity with electronic validation documentation systems (e.g., Windchill, KNEAT).

Strong technical writing skills for authoring validation protocols and reports.

Permanent