Commissioning and Qualification Engineering Lead

September 16

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Novartis

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Cardiovascular • Immunology • Neuroscience • Solid Tumors • Hematology

10,000+

Description

• Manage equipment, facility, utility, process, primary packaging validation activities • Ensure compliance with cGMP requirements and global regulatory expectations • Lead site C&Q planning and maintain master plans for projects • Design, execute, and document experiments for product process validation

Requirements

• Bachelor's degree is required; Master's Degree is preferred • 5+ years’ relevant experience in a GMP pharma environment is required • Experience in executing CQV, having led and managed validation projects is required • Direct experience in an aseptic manufacturing setting is highly preferred • Expert in reviewing and writing technical reports

Benefits

• Full range of medical benefits • Financial benefits • 401(k) eligibility • Paid time off benefits including vacation, sick time, and parental leave