Sr Manufacturing Technician-Protein Purification 1st Shift Wed-Sat
Shire - Massachusetts

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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.

Responsibilities

70% 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

15% 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

15% 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 and 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.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Shire - 17 months ago - save job
About this company
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Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...