Senior Manufacturing Technician

Summary of Position

The role of a Senior 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 Senior 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).  

Schedule:

• Saturday – Wednesday (4 ten hour shifts per week; 3 rotations) 
• Work Hours: 5:00 PM to 3:30 AM  
• Ability to work overtime when necessary 

Essential Functions

• Demonstrates an ability to provide directional leadership on the floor.
• Follows quality, safety, regulatory guidance’s and written procedures.
• Is an active member with continuous improvement.
• Ensures the maintenance and cleanliness of department, premises and equipment.
• Performs documentation in accordance with cGMP guidelines.
• Properly reviews Batch Records.
• Works with team to drive team environment.
• Follows all written procedures and verbal instructions.  
• Communicates effectively through written or spoken instructions.  
• Takes full ownership and accountability of process. 
• Works with coordinator to resolve challenges. 
• Works with leadership to improve operations.
• 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.).

Requirements

• Associate Degree or completion of an equivalent certification program from a technical or vocational school is required. Equivalent relevant years of experience in this field of study will also be considered.  
• Three or more years of relevant work experience is required, preferably in a pharmaceutical or manufacturing industry. 
• Experience working in an FDA-regulated cGMP environment is preferred.  
• Strong mechanical aptitude is required, scientific background is preferred.  
• 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.