Manufacturing Tech II, Lyophilization - 1st shift

Manufacturing Tech II, Lyophilization

The Manufacturing Technician of Lyophilization II is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. The Manufacturing Technician of Lyophilization II is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area.

This position initiates minor revisions to existing documents. The incumbent can troubleshoot simple existing procedures. All of the specific requirements presented in this job description are applicable to the functional area in which it resides. This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. The scheduled start time for this position is 8:00 AM, depending on business needs, with a consistent schedule once assigned.

Any exceptions to the assigned schedule must be approved by the manager in advance.

Duties and Responsibilities

• Work closely with supervisor and planner to ensure builds occur on time
• Confirm raw materials are received, prepared, and ready for manufacturing builds
• Ability to solve problems or escalate, as need
• Follow established procedures and training
• Follow GMP and GDP
• Ensure materials are appropriately handled
• Commit to a high degree of detail, quality, and focus
• Keep associated clean rooms stocked and ready for use
• Ensure all work is completed on time
• Coordinate smooth transfers between shifts
• Coordinate with other departments to help ensure all AMS goals are achieved
• Understand lyophilization technology
• Formulation experience
• Understand scientific units of measure
• Ability to pass visual acuity exam according to SOP guidelines
• As needed, support coverage of work outside of the normal shift hours and on weekends

Education and Experience Requirements

• High school diploma or equivalent
• Associate's or Bachelor's degree, preferred
• 2 years of manufacturing experience in a cleanroom environment following GMP and GDP is strongly preferred
• Computer proficiency
• Ability to interface and communicate well with cross-functional teammates
• Must be accountable, proactive, be able to speak up, provide feedback, and communicate openly and honestly