Validation Engineer or Specialist II, Equipment

United Therapeutics • Rtp, NC

6h • Onsite

About The Position

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.

You're looking for an opportunity to plant your roots and find a Validation department you can continue to grow within for the remainder of your career. You have experience supporting the validation of a variety of Production and Packaging equipment and want to continue to expand your expertise in support of those areas. The Validation Engineer or Specialist II, Equipment will perform activities in support of equipment qualification including developing and reviewing protocols and final reports, representing Validation on project teams, and assisting in preparing Validation change control requests and assessments. Work under general supervision to apply broadening and developing validation expertise, skills, experience, and knowledge at the professional level to apply a solid working knowledge of equipment validation to resolve moderately complex issues and consult with higher-level staff for more complex issues

Requirements

• The Validation Engineer II, Equipment requires Bachelor’s Degree in an engineering field while Validation Specialist II, Equipment Requires a Bachelor's Degree in a Scientific Field
• 2+ years of relevant validation 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, management and senior management - cross-functionally
• Easily adapts to change
• Ability to influence and may provide guidance to junior or support team members.
• Ability to work with minimal supervision
• Working knowledge of validation datalogger software (Amphenol/Ellab) use to perform temperature/humidity mapping.
• Working knowledge of TrackWise, MasterControl, Blue Mountain RAM or comparable quality systems and/or electronic document management systems
• Working knowledge of regulatory requirements from the US FDA and EU
• Ability to communicate with regulatory agencies, when applicable
• Ability to qualify Solid Dose, Dry Powder, API, Fill Finish, and/or Packaging processing equipment

Nice To Haves

• Ability to qualify QC/analytical equipment that may include HPLC, UPLC, Spectrophotometers, LAL Readers, TOC Analyzers
• Ability to qualify processing equipment that may include Autoclaves, Isolators, Bioreactors, Tanks, Depyrogenation Tunnel, Blow Fill Seal, Fluid Bed Granulator, Tablet Press, Tablet Coaters, Packaging Lines, Spray Dryers, Vision Inspection Systems
• Ability to quality utilities that may include Purified Water Systems, Compressed Air System, Nitrogen, HVAC, WFI System

Responsibilities

• Develop and execute protocols and summarize reports supporting validation of equipment, computer systems and processes
• Collect, compile and analyze validation data and information with some or minimal supervision, demonstrating ownership of data to confirm the validated state of the equipment for GMP use
• Participate on project teams requiring validation support to represent the function internally on specific projects
• Exercise judgment within generally defined procedures and practices to determine appropriate action or to recommend alternative solutions
• Communicate effectively, both written and orally, with colleagues and management cross-functionally, to provide the status of validation activities.
• Collaborate with peers and senior colleagues
• Contribute to the Validation organization to ensure department goals and objectives are met. Contributions may include leading small initiatives with limited resource requirements, and/or complexity
• Support change control activities from a validation perspective in order to meet department goals and objectives
• Revise validation SOPs and lifecycle validation documentation
• Perform equipment and other validation related requalifications and periodic reviews with general supervision

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level