|Company/Legal Entity USA Novartis Vaccines and Diagnostics, Inc. Holly Springs, NC
Functional Area Production
Job Type Full Time
Employment Type Permanent
Job Description Job Purpose: Responsible for engineering support of process systems used in formulation, filling and packaging for a Cell Culture based Flu Vaccine manufacturing facility to be located in Holly Springs, NC.
• Provide review for process equipment and/or facility designs.
• Provide engineering support for the design, procurement, fabrication and/or commissioning phases associated with the assigned process systems.
• Lead operational efficiency projects on assigned equipment systems.
• Troubleshoot equipment related issues and develop sound engineering solutions to address identified problems.
• Monitor equipment and process performance during manufacturing to identify improvement opportunites.
• Manage change controls related to system improvements for equipment or product transfers.
• Provide technical review of automation system design documents for assigned systems.
• Support engineering project execution across multiple manufacturing areas as required.
Minimum requirements Requirements:
• BS Mechanical or Chemical Engineering or related field.
• Minimum 2 years related industry experience required.
• 1+ years experience in pharmaceutical/biotech operations, with thorough working knowledge production unit operations and validation principles.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
• Design experience or owners experience in formulation, filling and packaging required, with an emphasis on syringe filling and VHP isolator technology for sterile products.
• Knowledge of the process for filling or formulation required.
Note: Position can be upgraded based on experience and education level.
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