Manufacturing Technician

The Manufacturing Technician will perform all tasks associated with Aseptic production under cGMP Guidelines to meet production demands. This position will report to the Cold Products Aseptic Suite Supervisor.

Schedule: Monday-Thursday 0500-1530.Weekend and off shift overtime as needed.

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP's and FDA regulations.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the area.
• Set up, operate, dispense, maintain equipment in a class 100 areas according to SOP and in compliance with cGMP guidelines.
• Perform documentation in accordance with cGMP guidelines.
• Dedicated to providing the highest quality product and meeting the expectations and requirements of internal and external customers.
• Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
• 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.
• Clean production equipment and processes in accordance with current good manufacturing practices and standard operating procedures in a controlled area.
• 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.
• Calibrate or adjust equipment to ensure quality production, using internal calibration functions.
• Take ownership and accountability of equipment, processes, and area assigned to or related to the production process.
• Responsibilities also include the ability to lift, reach, pull, and squat as needed, according to production demands.
• Ability to identify and verify appropriate materials, area conditions, process for production and address any abnormalities in the process, with materials or in area conditions in collaboration with Quality and leadership.
• Use logical methods to solve difficult problems with effective solutions and is able to makes sound decisions in a timely manner.
• 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.).

• Associate Degree preferred, High school diploma or equivalent required.
• 1 or more years of relevant work experience required (regulated environment, attention to detail and following detailed instruction).
• Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards.
• Willingness to work rotating shifts, weekends, and overtime, as necessary.
• Proven high performer capable of meeting or exceeding goals on time as well as meeting objectives of the team.
• Exemplary team building behavior and a proven collaborative attitude.
• Capable of adjusting to changes and dealing effectively with uncertainties in the workplace.
• Demonstrated willingness to be flexible and adaptable to the needs of the department and business.
• Ability and desire to cooperate, collaborate, and partner with others.
• Takes ownership and accountability for the production process, assigned production area, production equipment and associated documentation.Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
• Thoroughly understanding the needs of internal/external customers and making customer satisfaction a top priority.
• Dedicated to providing the highest quality product and meeting the expectations and requirements of internal and external customers.
• Good interpersonal skills and ability to communicate information in a timely manner to those who need the information.

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 physicallynegotiate 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.