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-Works closely with Chemical Development, Production, and Quality Departments.
-Manages the transfer of assigned products and/or new processes into manufacturing.
-Trains production personnel on the execution of Batch Log Records, Cleaning Log Records and validation protocols.
-Provides input for and monitors actual manufacturing costs for assigned products.
-Reviews production campaigns and summarizes in Campaign Reports.
-Identifies and implements cost reduction projects.
-Provides technical support to production for assigned products.
-Acts as manufacturing representative on capital projects involving assigned products. -Conducts product/process failure investigations as appropriate.
-Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct.
-Implements and adheres to all applicable SHE, DEA, and cGMP regulations.
- Familiarity with equipment specification and qualification, deviations, CR’s, MBR’s, IQOQ’s, writing procedures, Visalia, and Blue Mountain maintenance system a plus.
SUPERVISION: The incumbent must be able to give technical directions to chemical operators.
EDUCATION AND EXPERIENCE: -A 4-year degree in Chemical Engineering and 0-5 years of hands-on experience in a pharmaceutical or fine chemical batch plant are required.
-Working knowledge of cGMP is required
-Pharma is a plus
OTHER REQUIREMENTS: -Must have excellent verbal and written communication skills
-Must be very conscientious and detail-oriented
-Must be able to work efficiently with people of all levels and cultures
-Must be a team player -Must be a self-starter and initiator
-Must be able to manage projects and prioritize appropriately
-Must have knowledge of organic chemistry
-Must have knowledge of standard process equipment
-Must have excellent computer skills (MS Office)