Reagent Bulk & Fill Technician IV

Responsibilities

• Lead manufacturing run activities including all applicable pre-production and post-production tasks
• Provide leadership and guidance to manufacturing associates
• Focus on fill/finish manufacturing
• Guide and lead the work of department associates executing daily operations
• Ensure production operations are conducted in compliance with policies, regulatory (GMP, FDA, ISO) and safety requirements
• Coordinate pre-production checks and activities
• Troubleshoot and resolve applicable technical issues
• Coordinate and execute applicable analytical testing activities
• Assist with batch record review and corrections
• Manage investigations and corrective/preventative actions
• Foster positive teamwork environment

• At least a Bachelors in biological or physical sciences
• At least 6 years of experience in the biotechnology/medical device industry
• At least 5 years of experience supporting a GMP environment
• Must have a thorough knowledge of cGMPs
• Computer skills are required (Word, Excel, Outlook)
• SAP, ATLAS, and Track Wise based system knowledge a plus
• Strong technical knowledge in commercial Purification and separation techniques
• Strong troubleshooting abilities
• Strong interpersonal and cross functional team building skills
• Must have experience supporting and/or leading deviation investigations