Job Description

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Principal Manufacturing Technician performs all tasks associated with the preparation, formulation, sterilization, dispensing, inspecting, labeling, and packaging 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 the Cold Products Packaging and Aseptic Suite Group. This position will report to the Cold Products Sterile Core Supervisor.

Schedule

Monday-Thursday 0500-1530

Weekend and off shift overtime as needed

Essential Functions

• Demonstrates an ability to lead in a fast paced environment in regards to production goals, standards, mindsets and behaviors both on and off the production floor.
• Ensure strict adherence to quality, safety, regulatory and written procedures in the manufacture of products in accordance with OSHA and CFR (cGMP) guidelines.
• Ensure vigilance to the production schedule to meet customer demands and reduce overtime (ensure most effective and efficient use of personnel, materials and time).
• Demonstrates a willingness to be flexible and adaptable to the needs of the department and business.
• 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.
• Ensure the maintenance and cleanliness of department, premises and equipment.
• Perform Batch Record calculations (including complex calculations) and maintain all documentation according to SOPs and cGMP Guidelines. Review documentation, make corrections, and sign off as required by SOPs and cGMP Guidelines.
• Monitor product quality to ensure compliance with standards and specifications.
• 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.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
• Follow all written procedures and verbal instructions and communicate effectively, both written and verbally.
• Inspect in-process and finished products for quality and adherence to customer specifications.
• 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.
• Take full ownership and accountability of equipment, process and area assigned to or related to production process.
• Use logical methods to solve difficult problems with effective solutions and is able to makes sound decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick quality decision.

Requirements

• Associate Degree preferred, High school diploma or equivalent required.
• Six or more years of manufacturing experience required (regulated environment, attention to detail and following detailed instruction}.
• Knowledge of Good Manufacturing Practices c(GMP} and applicable Quality System Standards.
• 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.
• Strong mechanical aptitude as well as scientific background.
• Able to provide front line troubleshooting of equipment/process issues.
• Thorough understanding of the needs of internal/external customers and ensuring customer satisfaction a top priority.
• Capable of adjusting to changes and dealing effectively with uncertainties in the workplace.
• Experience generating new and valuable ideas and effective solutions to difficult problems; connecting previously unrelated notions.
• Strong motivation and ability to achieve work goals and quantifiable business results.
• Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
• Demonstrated willingness to be flexible and adaptable to the needs of the department and business.
• Knowledge of Good Manufacturing Practices c(GMP)’s and applicable Quality System Standards.
• 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.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.