Manufacturing Operations Lead & Training Specialist

• Lead operational efforts and identify process improvements to increase efficiency.
• Implement and oversee process workflows production operations schedules and equipment utilization for medical isotopes to ensure the required production output is achieved.
• Oversee production of medical radioisotope products (including raw material preparation line clearance cleaning equipment/instrument setup etc.).
• Maintain compliance with cGMP practices policies and procedures.
• Coordinate with key stakeholders in the organization to ensure production objectives are met and staff are properly developed and trained.
• Support efforts to maintain quality requirements for various certifications (cGMP ISO1345:2016)
• Maintain competencies to serve in shift lead and HCRP roles.
• Within the department and across the organization foster a culture of respect safety quality and continuous improvement aligning with the mission vision and values of the organization.
• Responsible for the onboarding training development and evaluation of team members.
• Responsible for the Ac225 Training program maintaining associated procedures and training materials and ensuring compliance to regulations.
• Maintain operational compliance with applicable regulatory agencies and guidelines (i.e. FDA EU ISO USP NRC cGMP etc.).
• Coordinate with the Quality department all cGMP Training and other assigned training courses for Ac225 staff.
• Assemble analyze and report metrics on the state of the Training Program to ensure regulatory compliance identify trends and areas of improvement on a routine basis to management.

• Bachelor degree in science/engineering field or equivalent education/experience
  • Chemistry biochemistry chemical engineering or related field
• 4 years experience working in a chemical laboratory or related field and working with the following:
  • Radioactive material
  • Ongoing/routine production environment
  • cGMP regulated work
• 3 years of relevant experience managing Training projects including timelines resources and deliverables.
• Minimum of 3 years experience providing mentoring and skill development coaching.
• Experience with various Training tracking metrics including identification use interpretation trend identification/analysis and presentation.
• Analytical and problemsolving skills; excellent interpersonal written and oral communication skills.
• Organizational and project management skills for self and teams.
• Ability to manage multiple priorities simultaneously while meeting deadlines.
• Proven ability to effectively convey information engage with trainees and facilitate discussions.
• The ability to adjust training plans and methods based on learner needs and feedback.
• Expertly performs in a teamoriented collaborative environment.
• Embraces and models the Niowave Values of Teamwork Courage Integrity and Upright Zeal.
• Understands how to integrate into a new team/organization appreciates the history of current state know how and when to make suggestions as well as using just the right pace to reach the improved future state.
• Understands your own communication and learning styles can assess others styles and is able to find the right path to connect the two.

• Masters degree in science/engineering field or equivalent education/experience
• Chemistry biochemistry chemical engineering or related field
• Formal education in Instructional Design or Training Development.
• Work experience is considered in lieu of degree.
• Experience with instructional design and assessment configuration; experience developing training media and computerbased training design and development.
• Experience with electronic Learning Management Systems.

• Fulltime position.
• The companys standard operating hours are Monday thru Friday 6a 6p with productionrelated activities requiring 24/7/365 shifts.
• This position is a part of shift work including nights weekends and holidays.
• Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.

Required Experience:

Unclear Seniority