Validation Engineer

Stanford Common

9 months ago

Applications closed

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Position Summary:

The Validation Specialist is responsible for performing manufacturing, packaging, and cleaning validation studies for solid dosage pharmaceutical manufacturing and packaging.
Must have validation experience of:
Chromatography
Vessels
Equipment
Utilities and preferably Vaccines

Responsibilities: Responsibilities include, but are not limited to:

Design and develop validation strategy for manufacturing, packaging, and cleaning validation.
Prepare, review and execute Process Validation protocol for the Manufacturing and Packaging process.
Prepare final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements.
Work with other departments regarding deviations, out of tolerance conditions and equipment issues observed during validation by conducting failure analysis, determining the root cause, and taking corrective actions.
Work with the R&D, Quality and Project Management team to determine Process and Cleaning Validation requirement for the New Products introduced to CPC.
Perform product cleaning evaluation and document cleaning validation acceptance limits for process.
Assist with change controls, investigations for process deviations and corrective actions as needed.
Maintain and keep up to date database related to status of the manufacturing and packaging process validation.
Coordinate and execute validation protocol activities with consistent and effective communication with affected departments working autonomously while keeping the manager updated regularly.
Act as a backup and provide support in preparation, execution of IQ/OQ/PQ of manufacturing and packaging equipments, facility and critical utilities system.
Prepare, review, and execute packaging engineering study protocol and generate report.
Prepare, review, and execute qualification and temperature mapping studies for warehouse storage area and special temperature-controlled areas.
Develop and recommend science-based solutions with a focus on continuous improvement and compliance

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