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, 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 Company’s Beloit, WI facility.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.This position will assist the product and process development teams with creation and implementation of
simple to complex manufacturing process designs in compliance with cGMP regulations.
This position will be responsible for defining and creating new procedures for documenting or qualifying equipment/processing which can be transitioned to manufacturing production engineering team members.
The successful candidate will be familiar with manufacturing within the medical device/pharmaceutical industry and possess in depth engineering knowledge in science.
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. Exhibit the behaviors and core values that support Company’s Mission.
13. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
14. Support Companyr’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
Proficient knowledge of Microsoft Office Suite software programs, including Excel, Word, and Outlook.
Supervise the selection, training, development, appraisal, and work assignments of personnel.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals and governmental regulations. Ability to write reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
· Intense Customer Focus – Customer centric approach and seeks best customer experience
· Can-Do Mindset – Solutions oriented, maintains a positive attitude, able to handle multiple tasks/projects simultaneously in a fast-paced regulated environment
· Open-Minded Intelligence - Adaptable to change in the work environment and embraces diversity
· Proactive - Has a bias toward action, anticipates and prevents issues, identifies opportunities and blind spots
· Collaborative – Demonstrates an ability to work well with other team members, seeks out and accepts input, embraces teamwork to solve problems creatively
· Excellent communication skills - verbal and written
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is rarely required to stoop/bend, squat/crouch, kneel, climb, work at/above shoulder height with both hands, use both hands/arms for strong grasp and either hand to turn or twist, and may lift/carry and/or move up to 30 pounds frequently, and 75 pounds occasionally. The employee is occasionally required to walk, stand, push and pull. The employee is frequently required to sit, and may use both hands constantly for fine manipulation or finger dexterity. The employee may be required to handle loads up to 35 pounds above shoulder height, and loads up to 75 pounds below knuckle height. Specific vision abilities required by this job include near vision/acuity and visual color discrimination. The employee is also regularly required to speak and hear.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is moderate. While performing the duties of this job, the employee is occasionally exposed to elevated levels of heat, cold and airborne particles.