Lead eBR Systems Analyst, Operational Technology

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

The Lead eBR Systems Analyst of Operational Technology will drive the use of GxP electronic forms and batch records to eliminate paper recording of production data. This role will serve as a liaison between OT functional areas deploying and using electronic forms and batch records, providing the highest level of customer satisfaction and partnership, ensuring that OT services are delivered as committed. This person will work closely with the GxP functional areas, vendors, and system owners to understand their current requirements and future roadmap. Additionally they will provide key technical support for various manufacturing and manufacturing support systems such as OpsTrakker, and other GxP Applications and in a regulated, validated environment.

• Independently lead project management activities, including defining the scope of the project; creating a project schedule; tracking project progress; communicating with stakeholders; identifying and resolving system issues; leading prioritization; and managing project risks
• Manage continuous improvement project portfolio: Evaluate managed GxP and Quality systems, identify opportunities, and make recommendations to Quality and GxP operations' leadership.
• Perform and/or coordinate GxP and Quality systems configuration changes for applications in collaboration with functional business units and external consultants
• Review system design and scope and execute plans to ensure application meet business requirements and identify gaps
• Plan and manage training to end users for modifications to existing processes and/or new functionalities
• Lead project and support initiatives, day-to-day support, and off-hour activities on a day-to-day basis
• Coach and guide peers/junior team members on Opstrakker and other systems' configuration and business processes
• Create documentation and procedures to support the implementation and maintenance of managed GxP and Quality systems
• Drive the use of GxP electronic forms and batch records to eliminate paper recording of production data
• Collaborate with cross-functional teams, and Technical Teams to identify and resolve issues
• Manage GxP and Quality systems' updates
• All other duties as assigned

Minimum Requirements

Associate Degree in information technology, chemical engineering or bioengineering or an applicable scientific and/or engineering discipline preferred

10+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on delivering and administering MES, electronic batch record, or other systems with similar functionality with an Associate's Degree or

8+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on delivering and administering MES, electronic batch record, or other systems with similar functionality with a Bachelor's Degree or

6+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on delivering and administering MES, electronic batch record, or other systems with similar functionality with a Master's Degree

Demonstrated experience delivering electronic batch records, electronic forms, or equivalent in a GxP environment

Technical expertise with authoring and maintaining functionality of electronic batch records and electronic forms in a commercial platform

Excellent project management skills

Superior database maintenance / development experience

Computer hardware / software validation and change control experience

Knowledge and experience working in FDA CFR Part 11 compliant environment

Experience working on small, fast paced project teams

Ability to work under pressure and adhere to deadlines

Good verbal and written communications skills

Sound understanding of standard business practices

Preferred Qualifications

Bachelor’s Degree in information technology, chemical engineering or bioengineering or an applicable scientific and/or engineering discipline preferred or

Master’s Degree in information technology, chemical engineering or bioengineering or an applicable scientific and/or engineering discipline preferred

Certified Project Management Professional (PMP)-PMI

Technical expertise with authoring and maintaining electronic batch records and electronic forms in Opstrakker