Senior Manufacturing Technician

The role of a Senior Manufacturing Technician is to perform all tasks associated with operating equipment through formulation, preparation, dispensing and packaging of aseptically filled 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 technicians while coordinating work in accordance with standard operating procedures (SOP's).

Schedule: Sunday - Wednesday 2:30am - 1:00pm. Ability to work overtime when necessary

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP's as well as US and international regulations (i.e. FDA, HC, EU, TGA, etc.).
• Perform and document tasks associated with the production of radiopharmaceuticals in accordance with Federal and/or State guidelines in a cGMP environment.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the 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, Color Vision Test and Respiratory Test as required for process needs.
• Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
• Perform Batch Record calculations, reviews 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 good manufacturing practices and standard operating procedures.
• Ensures the maintenance and cleanliness of department, premises, and equipment.
• Order and maintain inventory of materials and supplies.
• Act as demonstrators and/or qualifiers for processes and procedures during the training of new employees.
• 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.).
• Works with leadership to improve operations.
• Must be willing to attend additional training when required.
• Demonstrates willingness to be flexible to the needs of the department and business, including outside of the department.
• Takes ownership and is an active member with continuous improvement activities including: reliability team meetings, root cause analysis, SOP and
• Batch record improvements, Kaizen events, and Customer Complaints.

• High School Diploma or equivalent required.
• Three or more years of relevant work experience is required, preferably in a pharmaceutical or manufacturing industry.
• 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.
• Experience working in an FDA-regulated cGMP environment is preferred.
• Must be capable of providing front line troubleshooting of manufacturing equipment and process issues, properly elevating concerns, and issues to appropriate personnel.
• 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.