Lead eBR Systems Analyst, Operational Technology

United Therapeutics Corporation•RTP, NC, NC

8d•Onsite

About The Position

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.

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

Nice To Haves

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

Responsibilities

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