Job Description

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.

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