Manufacturing Technician

The role of a Manufacturing Technician is to perform all tasks associated with operating equipment through formulation, preparation, and dispensing of aseptic fill radiopharmaceutical processes, according to cGMP guidelines to meet production demands. The Manufacturing Technician will work with advanced automated equipment, in the creation of new products, and serve as one of several lead technicians while coordinating work in accordance with standard operating procedures (SOP's).

Work Schedule: Monday, Tuesday, Thursday, Friday 8:30am - 6:30pm. Ability to work overtime when necessary.

• Follows quality, safety, regulatory guidance's and written procedures.
• Perform batch record calculations and maintain all documentation according to cGMP guidelines.
• Ensures the maintenance and cleanliness of department, premises and equipment.
• Follow detailed instructions and communicate effectively, both written and verbally.
• Performs documentation in accordance with cGMP guidelines.
• Properly reviews Batch Records.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the area.
• Follows all written procedures and verbal instructions.
• Takes full ownership and accountability of process.
• Works with coordinator to resolve challenges.
• Set up, operate, monitor, and clean production equipment and processes in accordance with cGMP's and SOP's.
• Must be willing to attend additional training/schooling when required.
• Ensures internal / external customer expectations are met or exceeded.
• Capable of adjusting to changes and dealing effectively with uncertainties in the workplace.
• Drives to achieve work goals and quantifiable business results.
• Collaborative attitude for business success.
• Demonstrates willingness to be flexible to the needs of the department and business.
• 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 with scientific background is preferred.
• One or more years of relevant work experience is required, preferably in a pharmaceutical or manufacturing industry.
• Good interpersonal skills and ability to communicate information in a timely manner.
• Takes ownership and accountability for the production process, assigned production area, and associated documentation.
• Must be capable of providing front line troubleshooting of manufacturing equipment and process issues, properly elevating concerns and issues to appropriate personnel.

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.