??? Become certified for entry into the GMP cleanroom space to be able to perform sanitization, stock/replenish supplies, equipment setup, and all related aseptic filling operations.??? Execute aseptic fill processes using batch records and SOPs.??? Responsible for verifying the calibration of all related equipment and sanitization of supplies to support production??? Increasing level of competency in the manufacturing area procedures. Assigned job duties will include Aseptic and clean room areas, Component Preparation, Filling and Capping??? Learn the functions necessary to work in the Fill suite. This will include the operation of the associated equipment.??? Ability to perform tasks with minimal supervisor direction.??? Provide training for new team members.??? Able to understand the manufacturing schedule and coordinate tasks to achieve the schedule.??? Provide floor leadership in the absence of a supervisor or PT3 technicians.??? Transport and/or dispose of hazardous chemicals.??? Perform all other duties as assigned.??? Must immediately notify supervisor if affected by an infectious disease or open lesions on the body, as individuals are not permitted to enter manufacturing areas or handle products if these conditions exist.
4-7 years
-B.S. degree in chemistry/biology/life sciences is a plus. -Extensive knowledge of and experience in bulk formulation along with equipment cleaning, preparation, and assembly are preferred. -Computer skills in Microsoft Office such as Word and Excel are a plus.
-High school diploma or the equivalent. -Minimum of five years of experience using current Good Manufacturing Practices (GMP) in a regulated manufacturing facility pharmaceutical/biotech/diagnostic industry) with Processing experience. -Adequate communication skills to read, comprehend, and discuss detailed GMP documentation (batch record instructions, Standard Operating Procedures, etc.). -Strong attention to detail. -Ability to perform arithmetic functions to accurately perform or check calculations required in manufacturing instructions. -Leadership experience in training/directing others. -Strong mechanical aptitude. -Ability to troubleshoot, identify problems, and propose solutions. -While performing the duties of this job, the employee is regularly required to use their hands and arms. The employee is frequently required to stand. -The employee must regularly lift and /or move up to 10 pounds, and frequently lift and/or move up to 25 pounds. -Isolator experience
High School
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