What Nuclear Manufacturing contributes to Cardinal Health
Nuclear Manufacturing is responsible for the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e. FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring.

The primary work environment consists of a cyclotron and associated manufacturing facility for the production of PET radiopharmaceuticals, which must be kept clean, orderly, properly lighted and maintained in optimum operating condition.  Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.  The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group.  Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation.  Noise levels are considered low to moderate. 

Responsibilities in this role Successfully complete extensive training, including e-learning assignments and hands on components, to demonstrate and maintain proficiency

• Ability to execute Standard Operating Procedures (SOPs) in accordance with
  current Good Manufacturing Practices (cGMP) requirements including Good
  Documentation Practices (GDP)
• Ability to manage inventory
• Monitor and verify quality in accordance with SOPs
• Ability to perform general maintenance and cleaning of equipment and facility
• Work in partnership with cross functional teams to ensure product/production
  expectations and demands are met
• Disciplined approach to adhering to a large volume of SOPs, with the ability to
  adapt to process improvement
• Ability to learn and utilize technology to support manufacturing processes
• Must be knowledgeable on analyzing chemical chromatography data and be able to troubleshoot analytical equipment (ie Gas chromatography and HPLC)

Schedule  40 hours per week. Monday through Friday from 10:00p to 6:00a. Candidate may be required to work different days, hours, and schedules based on business needs.

Accountabilities

• Support the manufacturing activities from internal product development and external sponsors.
• Receive, sample, store and/or distribute all materials required for production.
• Facilitate day-to-day operation and maintenance of the facility, production equipment, and testing instrumentation.
• Perform hands-on execution of manufacturing procedures, following standard operating procedures (SOPs) and master batch records (MBRs).
• Lead and/or support investigations and documentation of deviations and exceptions.
• Clean, maintain, and calibration/qualify all production equipment.
• Record and maintain systems regarding cGMP compliance such as consumable inventory levels, area classification requirements, or site environmental monitoring.
• Communicate all issues related to safety, quality, and compliance to site leadership.
• Handle radioactive materials for production and equipment calibration purposes, following established radiation safety procedures and guidelines.

Qualifications

• Bachelor's degree in life sciences or engineering preferred.
• At least 2 years of experience working in a GMP manufacturing environment in the pharmaceutical or biotechnology industry preferred.
• Demonstrated familiarity with the operation, use and cleaning of laboratory scale production equipment.
• Experience working in clean rooms/ISO5-8 environments/isolators not required, but is a plus.
• Experience working with radioactive isotopes not required but is a plus
• Must be able to work overnight shift (Facility operates at night.)
• Prior experience in manufacturing, preferably in a controlled environment and/or regulated industry desired.
• Effective written and verbal English communication skills required
• Able to repeatedly follow detailed processing instructions
• Ability to manage several tasks at the same time; Ability to evaluate operating conditions and exercise sound judgment and problem solving skills.
• Lifting: Frequent lifting between 50-75 lbs.
• Ability to see fine particulate and differentiate colors in liquid solutions.
• Ability to hear, write (English), and speak (English) clearly in order to communicate in manufacturing setting. 
• Manual dexterity required for equipment operation and occasional reach and lifting of small objects.
• Ability to be an effective team member.
• Demonstrated proficiency with the operation, use and cleaning of laboratory scale production equipment and conventional analytical instrumentation.
• Ability to work in a controlled environment requiring special gowning; experience performing aseptic manufacturing operations preferred.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements; ability to clearly document all work activities in a timely manner.
• Motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
• Flexibility to work periodic off-shift hours in support of routine production and testing needs.
• Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.