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Development Engineer I

Location
Rochester, Minnesota
Posted
29 Jul 2022

Rion is a biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion's mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.

Position Summary:

This position is for an engineer/scientist focused on pharmaceutical/biologics manufacturing located in Rochester, MN. This position will support process development and early clinical manufacturing. The ideal candidate will have strong laboratory skills and ability to work independently and as a member of a small team. This is a hands-on role to support both current and future development and manufacturing of cutting-edge biopharmaceutical products.

Job Responsibilities:

Forward thinking/technical operations including:

 

  • Support process and new product development activities and transfer to the manufacturing area.
  • Work with scientists to plan and execute experiments and collect accurate data.
  • Generate reports to support manufacturing changes in a regulatory compliant manner.
  • Troubleshoot manufacturing processes and propose solutions.
  • Identify opportunities to improve process efficiency and work with development team to determine the best plan of action for implementation.
  • Develop expertise in specific areas of manufacturing (SME).
  • Be an advocate for safety in all operations.
  • Work with technical drawings, spec sheets, drawings, requirements, and computers to complete tasks.
  • Perform DOE studies and use CpK/PpK analysis to track process success

 

Assist manufacturing (internal and CMOs) to perform operations for biopharmaceutical manufacturing including:

 

  • Tech transfer of new and updated processes to CMOs including training of operators to new processes.
  • Executing batches following cGMP and GDP principles (as needed)
  • Writing and reviewing documents including necessary FDA compliant work instructions/batch records/forms/SOPs
  • Routinely participating in new procedure planning and implementation into the manufacturing area.
  • Escalating production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to appropriate functional area(s).
  • Assist with performing routine maintenance of production equipment and production suites.
  • Troubleshooting of mechanical issues that arise with manufacturing equipment.
  • Ensuring manufacturing and development areas are always ready for regulatory body inspections.
  • Deviation identification, support investigations and CAPA support.


 

Basic Requirements:

 

  • Bachelor's degree in a science or engineering discipline or equivalent level of proven technical experience.
  • Detail oriented and self-motivated with strong written and verbal communication skills.
  • Ability to work independently/autonomously, within prescribed guidelines, or as a team member.
  • Demonstrated ability to follow detailed directions in a manufacturing GMP environment or equivalent.

 

Preferred requirements:

 

  • Two (2) years of experience in a manufacturing/process development environment.
  • LEAN, Six-Sigma, or other efficiency program experience
  • Experience manufacturing in a pharmaceutical/medical device environment.
  • Experience leading a team
  • Experience with pharmaceutical/medical device filtration and single use systems.


Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives.

We provide a highly competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion:


  • Comprehensive benefits package including company equity
  • Health Insurance including PPO or High Deductible Health Plan with Health Savings Account
  • Dental Insurance
  • Vision Insurance
  • Flexible Spending Accounts (FSA)
  • 401K or IRA Retirement Savings
  • Life Insurance basic life and supplemental life insurance options for self, spouse, children
  • Short and Long-Term Disability Insurance
  • Paid Family Leave (if applicable)
  • Paid Time Off
  • Paid Holidays
  • Parking benefits


Rion is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.


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Details

  • Job Reference: 671168650-2
  • Date Posted: 29 July 2022
  • Recruiter: Rion
  • Location: Rochester, Minnesota
  • Salary: On Application