Posted on 21st September 2018
Manufacturing Engineer Technician II – Reactor Hot Products
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Our North American headquarters is in Maryland Heights, MO. Come grow with us!
Summary of Position:
Performs all tasks associated with assembling, formulating, dispensing, and packaging of radioactive components Reactor Hot Products (RHP) Lab according to cGMP guidelines in order to meet production demands.
Position and Schedule:
Work hours (10 hour shifts):
Saturday 5:30 pm to Sunday 4:00 am.
Sunday 5:30 pm to Monday 4:00 am.
Monday 5:30 pm to Tuesday 4:00 am.
Tuesday 5:30 pm to Wednesday 4:00 am.
Some overtime may be required based on business needs.
- Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s. Ensure the maintenance of their department, premises and equipment.
- Conduct room release to check for exceptions that would hinder effective production.
- Ensure proper maintenance and cleanliness of department (structure of area), premises (facilities) and equipment (all equipment and tools), report any deficiencies to coordinator and/or supervisor.
- Walk-through to check for irregularities that would hinder effective production.
- Perform line clearance to ensure nothing left from the previous lot and that the room is clean.
- Keep extensive log books to record important information in order to ensure compliance.
- Set up, maintain, operate and clean equipment and work area according SOPs and cGMP guidelines. Immediate report any item not working or in proper cGMP condition.
- Pick up and deliver raw materials from loading dock to production area using pallet jacks.
- Demonstrate the ability to participate in the manufacturing process. Demonstrate proficiency and understanding of the operation and associated documentation requirements for production in a reasonable period of time.
- Participate effectively within the department team environment and interact with multiple departments to ensure the operational success of the facility.
- Train on aspects of the manufacturing process in the area(s) including but not limited to: overall process, individual task, trouble shooting, escalation plan, safety concerns, documentation, cleaning, cGMPs, SOPs, company policies, gowning and lean processes such as 5S and Kiazen.
- Perform Batch Record calculations (including complex calculations) and maintain all documentation according to SOPs and cGMP Guidelines.
- Operate telemanipulators during the manufacturing processes.
- Accurately label selected products with tracking and the appropriate FDA labels.
- Accurately count materials and labels to track used and unused raw materials for placement in the batch record.
- Demonstrate the ability to participate in the production processes with supervisor and/or leadership support. Monitor product quality to ensure compliance with standards and specifications.
- Awareness of FDA, NRC, ALARA, and OSHA requirements.
- Ability to identify and verify appropriate materials, area conditions, process for production and elevate any abnormalities in the process, with materials or in area conditions to coordinator and/or supervisor.
- Assist and support (when appropriate), investigation, reliability team meeting, root cause analysis, SOP and Batch record improvements, Kaizen, Customer Complaints, data collection and downtime issue resolutions.
- Provide and maintain a safe work environment by participating in safety programs, committees, or teams and by conducting laboratory or plant safety audits.
- Prepare some chemical solutions for products or processes, following standardized formulas, or create experimental formulas.
- Maintain, clean, or sterilize laboratory instruments or equipment.
- Provide technical support or assistance to chemists or engineers.
- Order and inventory materials to maintain supplies.
- Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
- Develop and train personnel to ensure a cross functional operations culture.
- Follow all written procedures and verbal instructions and communicate effectively, both written and verbally.
- Required to perform other duties that are not routinely part of direct responsibilities based on direction of manager’s / supervisor’s discretion to support overall business needs.
- Wiliness to be flexible and adaptable to the needs of the department and business.
- Inspect finished products for quality and adherence to customer specifications.
- Set up and verify the functionality of safety equipment.
- Monitor and adjust production processes or equipment for quality and productivity.
- Troubleshoot problems with equipment, devices, or products.
- Test products or subassemblies for functionality or quality.
- Plan and lay out work to meet production and schedule requirements.
- Start up and shut down processing equipment.
- High school diploma or equivalent required. College level course work in Mechanics, Engineering Technical trade, or Chemistry preferred.
- 1 to 2 years of manufacturing experience preferred (regulated environment, attention to detail and following detailed instruction).
- Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards.
- Must be willing to work around radioactive and/or non-radioactive materials.
- Willingness to work rotating shifts, weekends, and overtime, as necessary.
- Effectively adjusts to changes and deals effectively with uncertainties in the workplace.
- Ability to generate new and valuable ideas and effective solutions to difficult problems; connects previously unrelated notions.
- Realizing the worth of all people and respects others, regardless of background or cultural differences.
- Thoroughly understanding the needs of internal/external customers and making customer satisfaction a top priority.
- Strong motivation and ability to achieve work goals and quantifiable business results.
- Ability and desire to cooperate, collaborate, and partner with others.
- Willingness to help outside your department and within your department outside your normal or assigned responsibilities.
- Has demonstrated the use of logical methods to solve problems with effective solutions and able to make a quick quality decisions.
- Ability to conduct a postmortem on a delays, production issues and problems and apply finds to the entire process.
- Dedicated to providing the highest quality product and meeting the expectations and requirements of internal and external customers.
- Has demonstrated willingness to be flexible and adaptable to the needs of the department and business.
- Enjoys the challenge of unfamiliar tasks.
- Enjoys working hard and seizes more opportunities than others for personal and professional growth.
- Is easy to approach and talk to, creates a climate in which people feel comfortable.
- Calm under pressure; does not become defensive or irritated when times are tough; is considered mature; doesn’t show frustration.
- Takes ownership and accountability for the production process, assigned production area, production equipment and associated documentation.
- Has demonstrated the functional and technical knowledge and skills to do the job at a high level of accomplishment and proficiency consistently.
- Good interpersonal skills and ability to communicate information in a timely manner to those who need the information.
- Drive self and team to schedule adherence and most efficient production process.
- Uses his/her time effectively and efficiently; concentrates his/her efforts on the more important priorities for the department.
- Knows personnel strengths, weaknesses, opportunities and limit; seeks feedback and open to criticism.
- Can effectively cope with change.
- Has knowledge of how the department works.
- Possesses some skills to develop, coach, and mentor others.
- Willing to take on challenges and stretch tasks.
- Standard office environment, coupled with approximately 50% time in radiopharmaceutical manufacturing and laboratory environments.
- Must be willing to wear a variety of personal protective equipment.
- 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 also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
- Must possess good hand-eye coordination.
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.
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