What are the responsibilities and job description for the Lead Validation Engineer or Specialist, Equipment position at United Therapeutics Corporation?
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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
Are you a validation professional looking to apply your expertise in a dynamic biotech and pharmaceutical environment? As a Lead Validation Engineer, Equipment, you’ll be a subject matter expert in equipment validation, playing a key role in ensuring the compliance and performance of critical manufacturing systems—including QC lab equipment, and upstream, downstream, and aseptic fill/finish manufacturing equipment. You’ll leverage your experience in developing sterilization cycles and writing validation protocols from scratch to support a fast-paced, highly regulated environment. This role offers the opportunity to lead complex validation projects, troubleshoot unique challenges, and collaborate across teams to uphold the highest industry standards. If you’re passionate about driving validation excellence and contributing to life-changing manufacturing for a rare disease population, we want to hear from you!
Minimum Requirements
United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location.
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.
The salary for this position ranges from $ 122,000 to 150,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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
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
Are you a validation professional looking to apply your expertise in a dynamic biotech and pharmaceutical environment? As a Lead Validation Engineer, Equipment, you’ll be a subject matter expert in equipment validation, playing a key role in ensuring the compliance and performance of critical manufacturing systems—including QC lab equipment, and upstream, downstream, and aseptic fill/finish manufacturing equipment. You’ll leverage your experience in developing sterilization cycles and writing validation protocols from scratch to support a fast-paced, highly regulated environment. This role offers the opportunity to lead complex validation projects, troubleshoot unique challenges, and collaborate across teams to uphold the highest industry standards. If you’re passionate about driving validation excellence and contributing to life-changing manufacturing for a rare disease population, we want to hear from you!
Minimum Requirements
- Bachelor’s Degree in an engineering field (those without an engineering degree will still be considered; however, the job title will be as a Validation Specialist)
- 8 years of relevant validation experience in a pharmaceutical/cGMP environment
- Proficient knowledge of US and international regulations related to validation activity
- Experience with Validation Datalogger Software (preferably Amphenol / Ellab)
- Ability to perform validation activities for equipment, process and/or computer-related validation protocols
- Ability to support test execution by either overseeing or else providing hands-on assistance during testing to either System Owners or Validation management
- Ability to interact and communicate with System Owners as the Validation Functional expert
- Use skills as an experienced professional with a full understanding of industry practices, company policies, company procedures, and guidance
- Ability to lead simultaneous activities requiring collaboration with internal and external groups to deliver validation projects, department initiatives, and periodic reviews on time and within budget
- Ability to provide feedback and recommendations to validation management regarding department work practices, procedures, and guidance
- Ability to anticipate project needs, potential gaps, and pitfalls through forecasting and estimations, which are based on prior experience
United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location.
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.
The salary for this position ranges from $ 122,000 to 150,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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
Salary : $122,000 - $150,000
