MS&T Specialist

• Work cross-functionally with other departments to effectively transfer and maintain processes in the facility
• Develop & implement process & system changes to improve production scale reliability & quality
• Prepare and execute procedures protocols reports and plans for assigned processes in a radiological environment
• Create and recommended maintenance strategies for relevant systems in collaboration with key stakeholders applying risk-based decision-making practices and balancing performance cost and risk
• Review and investigate system/equipment failure incidents formulate and record lessons learned and continually improve and optimize system operation and maintenance strategies through implementation of corrective and preventive actions
• Execute the creation of risk assessments gap analyses deviations change controls and CAPAs including determination of product or process impact root-cause analysis and corrective action and preventative action identification
• Execute chemistry and medical radioisotope testing operations. (including raw material preparations equipment setup and cleaning equipment/instrument setup etc.)
• Support the investigations & action items for NCMRs & CAPAs that occur during production operations
• Conduct cold chemistry preparations including making solutions columns compounds etc.

• Bachelors degree in science/engineering field or equivalent education/experience
  • Chemistry biochemistry chemical nuclear engineering or related field
• 3 years experience in a chemical laboratory or related field
• 2 years experience working with the following:
  • Radioactive materials
  • cGMP regulated environment
• Embraces and models the Niowave Core 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 best connect with colleagues
• Strong analytical and problem-solving skills
• Excellent interpersonal written and oral communication skills
• Highly developed organizational skills
• Demonstrates capability and regularly engages in mentoring others in the how & why of standard work

• Above items and.
• 6 years experience in a chemical laboratory or related field

• 7 years experience working with the following:
  • Pharmaceutical environment
  • Radioactive materials
  • cGMP regulated environment
• Masters degree in science/engineering field or equivalent education/experience preferred
• Experience operating in a cGMP CDMO or Finished Drug environment preferred

• Full-time position
• Niowaves standard operating hours are Monday Friday 6:00 a.m. 6:00 p.m. with production related activities requiring 24/7/365 shifts
• This position will have regular working hours Monday Friday with an expectation of adjusting work time outside of the standard operating hours as needed
• Niowave has multiple locations within the Lansing area and travel between locations is expected in the role

Required Experience:

IC