Manager, Isotope Manufacturing Engineering
The Manager, Isotopes Manufacturing Engineering is a hands on position responsible for the transfer of new isotopes production processes and systems into manufacturing, as well as on-going production support, validation, and process improvement for existing isotopes processes. This position involves a strong focus on day to day support of production lines to meet quality and production goals. The Manager of Isotopes Manufacturing Engineering will be responsible to help recruit for and manage a new team of Manufacturing Engineers responsible for the Isotopes production process at NorthStar’s Beloit, WI facility.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Manage engineering team responsible for, as well as provide hands on direct involvement, with the transfer of new isotope manufacturing processes/systems to production.
2. Provide manufacturing engineering representation and support on Isotopes processing system development projects to insure new production processing systems are ready for transfer to initial production and ongoing successful operation.
3. Manage/responsible for production documentation including work instructions and batch production records.
4. Develop/execute strategy for ongoing support and maintenance of new isotopes production processes and systems.
5. Plan and execute ongoing process improvements to meet quality and production goals.
6. Be involved, where possible, with Factory/Site Acceptance Testing of complex custom equipment
7. Develop/execute standards/processes for qualification and process validation
8. Ensure production equipment is capable and has capacity for growth, involving integrating equipment, people, material flow systems, and information systems.
9. Develop and maintain cGMP compliant process work instructions, batch production records, reports, and plan documentation
10. Establish system level metrics and test plans by collaborating with engineering and RA/QA teams to insure the product meets performance requirements involving accuracy, repeatability, and reliability.
11. Support complaint/event/CAPA/deviation/out of specification investigations
12. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
13. Support NorthStar’s Quality System and Safety and Health Program by following procedures and mentoring others.
Ability to travel internationally and domestically could be required, this is expected to be less than 10% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE
Bachelor’s Degree in Engineering and 8 years of experience in Manufacturing Engineering, along with 2 years of management experience; or equivalent combination of education and experience. Experience working in a regulated environment and executing process validation and documentation activities (IQ/OQ/PQ) required. Experience with developing/supporting processes in an ISO 8 clean room, working with radioactive materials, and experience in a pharmaceutical manufacturing environment preferred.
Proficient knowledge of Microsoft Office Suite software programs, including Excel, Word, and Outlook.
Supervise the selection, training, development, appraisal, and work assignments of personnel.
• Strong Multi-tasking skills
• Excellent problem solving skills
• Strong organizational and communication skills.
• Strong Mentorship skills.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line