Senior Manufacturing Engineer
Location: Eden Prairie, MN
Type: On-Site
Time Type: Full time
Posted: 3 Days Ago
End Date: October 18, 2024 (13 days left to apply)
Job Requisition ID: R03758
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. We have successfully gained FDA approval for five medicines, are always conducting new clinical trials, and are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs.
With over 100,000 patients on the organ transplant waitlist and only a fraction receiving the lifesaving organ they require, there is a great need for additional sources of transplantable organs. At Miromatrix, a leader in regenerative medicine and a subsidiary of United Therapeutics Corporation, we are working to address this unmet need by bioengineering human organs to help save and improve patients’ lives.
How you’ll contribute
The Senior Manufacturing Engineer position has the responsibility to ensure proper operations and maintenance of critical utilities and engineering processes/systems in support of the Engineering and Facilities department. Primary duties will focus on process support and improvement, equipment support and maintenance, equipment management system development, as well as coordinating vendors for service and maintenance.
Essential Job Duties & Responsibilities
- Apply systematic thinking and technical knowledge to improve and/or develop existing or new workflow processes
- Lead and author validation, verification and IQ/OQ protocols
- Support and continue development of the equipment management program
- Lead and assist in deviation investigations
- Author, revise, and approve controlled documents (e.g. Standard Operating Procedures)
- Communicate and collaborate cross-functionally
- Conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
- Independently address a broad range of non-routine to moderately complex problems
- Support engineer bioreactor control system quality documentation
Minimum Requirements
- Bachelor’s degree in mechanical engineering, Biomedical Engineering, or similar
- 5+ years of relevant industry experience with a bachelor's degree
- Experience in technical writing authoring SOPs, validation/verification plans, and IQ/OQs
- Experience solving advanced technical problems
- Knowledge of good documentation and good manufacturing practices
- Excellent written and oral communication skills
- Experience operating in a GxP/GMP environment
Preferred Qualifications
- Knowledge of kidney and liver biology, physiology, and cell types
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical/dental/vision/prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid-19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
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