What are the responsibilities and job description for the (Contractor) Equipment Specialist position at Curium Pharma?
Noblesville, IN, United States
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.
The Equipment Specialist is a key technical role within Curium Pharma's operations team to ensure implement process improvements and maintain the current state of the equipment. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge in aseptic filling, sterile processing, and/or labeling.
This position will partner and lead internal operations continuous improvement initiatives. The ideal candidate must understand and be able to adapt to the changing needs of a manufacturing environment while providing support to the process engineers and operations team in troubleshooting, repair and preventative maintenance of manufacturing equipment and processes. You will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. You will also be expected to demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving and solution driven thinking.
Work Schedule: Monday - Friday 8am-4:30pm
* Resolve issues that arise in day to day running of operation and providing timely responses and solutions
* Function closely with operations personnel to understand their interaction with equipment and resolve issues they face
* Implement solutions in collaboration with cross-functional technical teams and site leadership team
* Support filling equipment, formulation process, visual inspection equipment, and/or labeling process.
* Evaluate and improve efficiency of manufacturing instruments, equipment, and tools
* Evaluate and implement new changes
* Support operations through standard operating procedure revision
* Participate and/or support process FMEAs to understand process and product risks
* Provide technical support to manufacturing activities
* Work flexible hours to ensure production facility coverage
* 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.).
* Bachelor's degree in engineering field or Bachelor's degree in life sciences with 3 years of relevant work experience
* Or High School Diploma/GED 8 years of relevant work experience
* Lean Six Sigma Certification
* Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices
* Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), visual inspection, and labeling
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 anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Segment:
Biology, Biotech, Nuclear Engineering, Sterile Processing, Engineer, Science, Engineering, Healthcare
