Validation Specialist I, 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

You'll play an integral part in ensuring the compliance and performance of critical manufacturing systems—including QC lab equipment, and upstream, downstream, and aseptic fill/finish manufacturing equipment. The Validation Specialist I, Equipment will perform activities in support of equipment qualification including assisting in developing protocols and final reports.

• Work under general supervision to apply a foundational working knowledge of equipment validation at a professional level to resolve straightforward or standard issues and problems, referring more complex issues to higher-level staff. Utilize acquired skills, experience, and knowledge to apply a full understanding of industry practices and company policies and procedures to provide support to the manufacturing and quality control laboratory teams
• Develop and execute protocols and summarize reports supporting the validation of equipment, computer systems, and processes, as needed with oversight or consultation
• Assist team in collecting and compiling data in support of validation activities. Follow a well-established and familiar set of activities and /or processes to complete analysis or derive a solution
• Provide general support to the Validation organization to meet department goals and objectives by delivering on all assigned tasks
• Support validation change control activities from a validation perspective in order to generate change assessments
• Assist with revising validation SOPs and lifecycle validation documentation
• Communicate effectively, both written and orally, with colleagues and Validation management, to provide the status of validation activities
• Perform other duties as assigned
  
  
  

For this role you will need

Minimum Requirements

• Bachelor’s Degree in a scientific field
• 1+ years of relevant experience in a pharmaceutical/cGMP environment
• Working knowledge of Microsoft Office and email software
• Detail oriented, self-motivated, organized and have the ability to prioritize work
• Ability to communicate effectively, both written and orally with colleagues and management - cross-functionally
• Ability to work with supervision
• Ability to easily adapt to change
  
  
  

Preferred Qualifications

• Working knowledge of validation datalogger software (Amphenol/Ellab) use to perform temperature/humidity mapping
• Ability to qualify Solid Dose, API, Fill Finish, and Packaging processing equipment
• Working knowledge of TrackWise or comparable quality systems and/or electronic document management systems
• Working Knowledge of regulatory requirements from the US FDA and EU
  
  
  

Job Location

United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location.

The salary for this position ranges from $66,000 to $90,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.

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.