Engineering and Maintenance Manager for Tyvaso Dry Powder Inhaler Equipment

California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. 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. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are United Therapeutics supplies Dry Powder Inhalation (DPI) medicines from the RTP facility in North Carolina. The Engineering and Maintenance Equipment Manager will be instrumental in supporting a major increase in the production capacity at RTP to meet a growing patient need. The successful candidate will lead the recruitment of a new engineering/maintenance team to support operations and the qualification of manufacturing and packaging equipment to delivery Tyvaso medicine from a new ‘state of the art’ production facility. Partner with the cross functional Tyvaso DPI team to deliver product against a balanced scorecard, ensuring that all safety and quality/compliance standards are met to support the supply of medicines on time and within budget Direct and manage direct reports to include responsibilities for recruitment, training, coaching, mentoring, development, goal setting & achievement, performance evaluations/management and retention of a diverse workforce. Also manage contract personnel. Partner with DPI cross functional team members and external partners/inspectors to schedule and coordinate equipment activities. Responsibilities will include, but are not limited to: calibration associated with manufacturing equipment; partnering with OEM equipment suppliers, and coordination with local AHJs (e.g. NCDOL for inspections). Provide oversight for all types of work orders to include: utilizing RAM (Regulatory Asset Management software) to document the scheduling, completion and review of preventive and on-demand work orders; managing spare parts inventory; coordinating with third party support/vendors and ensuring the work has been completed; and managing issues including engagement of relevant stakeholders Ensure that safety issues and quality deviations associated with equipment performance are fully investigated and documented, and CAPAs are implemented to mitigate risk of repeat incidents Author the creation and ongoing revisions of documentation associated with Tyvaso DPI equipment use/repair/maintenance to include: SOPs, work orders, protocols, and Job Safety Analyses Assist and support in the planning of long and short-term organizational objectives by assisting in the preparation of the facility operational budgets with a focus on the Tyvaso DPI equipment capital budget Effectively communicate engineering needs and/or issues with senior leadership. Provide consultation and advice to management as it pertains to how Tyvaso DPI equipment operates. Minimum Requirements H.S. Diploma or General Education Degree (GED) 12 years of experience in a pharmaceutical, food, or chemical manufacturing environment in a engineering/maintenance position with a H.S. Diploma/GED or 10 years of experience in a pharmaceutical, food, or chemical manufacturing environment in a engineering/maintenance position with an Associates Degree or 8 years of experience in a pharmaceutical, food, or chemical manufacturing environment in a engineering/maintenance position with a Bachelor's Degree 3 years of experience with people management Must have (or be willing and able to obtain) a valid Passport Expertise and experience in leading equipment maintenance teams that supply complex regulated products Preferred Qualifications Associates Degree or Bachelor's Degree in a relevant field Bachelor’s Degree In a relevant field 6 years of experience in cGMP pharmaceutical manufacturing Experience with software for tracking and scheduling preventative maintenance events Demonstrated ability to apply GMP to company specific processes and products AutoCAD experience Job Location United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location. This position will require occasional domestic and international travel. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. 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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.