Manager, Equipment (Dry Powder Inhalation)
United Therapeutics
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
**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. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we 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 (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
**How you’ll contribute**
United Therapeutics supplies Dry Powder Inhalation (DPI) medicines from the RTP, NC facility. The DPI Equipment Manager is responsible for leading an equipment maintenance team across all unit processes associated with the manufacture of Tyvaso DPI. This role will ensure strict adherence to safety, quality and regulatory standards, and drive continuous improvement.
+ Provide leadership to the equipment maintenance team, fostering a culture of collaboration, accountability, and continuous improvement (new technologies and process optimization) across all shifts that support the Tyvaso DPI operation
+ 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.
+ Perform all other duties as required
**For this role you will need**
**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
+ Strong leadership skills
+ Expertise and experience in leading equipment maintenance teams that supply complex regulated products
+ Excellent written and oral communication skills with the ability to communicate effectively across all levels and functions of the business
+ Demonstrated ability to work in a highly regulated environment and ensure application of requirements to company specific processes and products
+ Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to manufacturing requirements
+ Customer focused, with the ability to multitask and maintain the quality of work. Ability to respond to escalated concerns to support off-shift operations as needed.
+ Ability to work independently and with minimal supervision, as well as in a heavily team-focused environment
+ Strong organizational and problem-solving skills
+ Experience in troubleshooting and repair of pneumatic, electronic, hydraulic and control systems
+ Microsoft Office, Outlook experience/knowledge
**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
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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_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
_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._
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