Sr Manufacturing Technician

  • Company: Shire plc
  • Location: Massachusetts, United States
  • Posted: November 10, 2017
  • Reference ID: R0015677
Primary Role:
With limited supervision this individual will perform routine and non routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Will support engineering and validation activities.

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Responsibilities include
• Troubleshoot and resolve process related issues
• Create work orders as needed
• Initiate and document minor deviations
• Execution of critical and routine and non routine production operations
• Informing management of events impacting schedule
• Perform Batch Record, Log Book and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS)
• Record data into log books
• Review manufacturing documentation real time to ensure compliance
• Coordinate sample preparation and testing
• Propose and review document revisions
• Carry out work in a safe manner, notifying management of safety issues and risks

This individual will manage equipment and support facility related projects by
• Initiating work orders
• Act as subject matter expert for improvement projects
• Perform scheduled cleaning of equipment
• Assembly and disassembly of process equipment
• Perform standardization of equipment
• Support change over activities
• Execution of equipment and process qualifications and validation

Working with supervision this individual will
• Provide technical training for area personnel
• Provide input on training material development
• Meet and maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self assessment

Education & Experience Requirements:
Normally requires a high school diploma and 4-6 years related industry experience or an Associates Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience. Biotech Certificate preferred

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