To work as a team member to process High Value Products (HVP) through the HVP process with minimal assistance from management or engineering. Team members must have the ability to work with other team members in a cell concept rotating through multiple job functions throughout the day following a playbook for optimal performance. Team members must be able to perform job functions with a full gown/goggles in which no skin is visible within the area for multiple hours at a time. Ideal candidates are quick thinking and confident to ensure consistent processing and foresight to know the next task required. It is the responsibility of this individual to ensure that product/customer specifications are followed always. Ideal candidates have previous cGMP experience and have the knowledge of how to operate within a classified clean room.

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Essential Duties and Responsibilities

• Strictly adhere to all requirements pertaining to gowning for entry into classified clean room areas.
• Candidates must be able to pass gowning qualifications to enter classified clean rooms.
• Accurately maintain all required documentation and paperwork to ensure lot traceability.
• Operate pharma wash equipment and oversee processes within classified clean rooms such as pre-staging, staging, loading, unloading and final packaging, per cGMP standards.
• Strict adherence to product/customer specifications.
• Ensure that weigh/count equipment is set up accurately and within calibration.
• Correctly sample product for QA inspections and pre-delivery samples in cGMP manner.
• Keep equipment and work area in clean and orderly condition.
• Operate Envision system correctly according to all applicable procedures.
• Operate steam sterilization process including but not limited to start functions such as loading, unloading and packaging.
• Input and log data correctly for the Autoclave process when needed.
• Perform all positive pressure and cleaning requirements for all classified cleanrooms associated with the HVP Processing department.
• Alert the Area Manager to conditions that may prevent meeting production and quality expectations.
• Operate PC, printers and scanners as required.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules

Education

• High school diploma or GED required.

Work Experience

• No mimimun work experience required.
• 2+ years of cGMP manufacturing experience preferred.

Preferred Knowledge, Skills and Abilities

• Must possess an acute attention to detail.
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP).
• General use of computer work station and ability to use SAP commands is preferred.
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities.
• Must be able to train and guide others as required.
• Must be able to read and write in English.

Travel Requirements

Physical Requirements