Manufacturing Technician

Performs all tasks associated with the preparation, formulation, sterilization, dispensing, inspecting, labeling, andpackaging of manufactured products according to cGMP Guidelines in order to meet production demands. Performs all tasks associated with the Sterile Core production area as well as providing backup support for theCold Products Packaging and Aseptic Suite Group. This position will report to the Cold Products Sterile Core Supervisor.

Schedule:
Monday- Thursday
5:30am-4:00pm
Weekend and off shift overtime as needed

• Ensure a safe and quality working environment through training, awareness, and compliance to safetyguidelines, SOP's and FDA regulations.
• Participate and perform effectively in a team environment and interact with multiple departments to ensurethe operational success of the area.
• This position will coordinate with Staging, Warehouse, Label Control, and Production Supervisors to plan,schedule, and execute all aspects of the area.
• Monitor and inspect product quality to ensure compliance with standards and specifications.
• Must pass Visual Acuity and Color Vision Test and must be able to lift 50lbs.
• Adhere to all applicable regulations, policies, and procedures for health, safety, and environmentalcompliance.
• Follow all written procedures and verbal instructions.
• Perform Batch Record calculations and maintain all documentation according to cGMP Guidelines.
• Follow detailed instructions and communicate effectively, both written and verbally.
• Set up, operate, monitor, and clean production equipment and processes in accordance with current goodmanufacturing practices and standard operating procedures.
• Order and maintain inventory of materials and supplies.
• Act as demonstrators and/or qualifiers for processes and procedures during the training of new employees.
• Assist in developing and revising SOPs as needed.
• Troubleshoot problems with equipment, devices, or products.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• High school diploma or equivalent required. College-level course work in Mechanics, Engineering Technical trade, or Chemistry preferred.
• 1 or more years of relevant manufacturing experience required (regulated environment, attention to detail, and following detailed instructions).
• Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards preferred.
• Willingness to work rotating shifts, weekends, and overtime, as necessary.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.