The job details are as follows:
What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.
In 2021, we became the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
How you’ll contribute
The Validation Engineer (SAP) performs validation activities in support of ERP computerized systems in a regulated environment including manufacturing, quality, procurement, warehouse management, and order processing. Additionally, the role can support use and validation of other GxP computer systems including QMS, CMS, LMS, LIMS, EDMS, ALM, QC Lab, Serialization, Medical Information Request, Drug Safety, Clinical CTMS, Clinical CDMS, Clinical TMF, EDC, and IRT. This role requires developing requirements specifications, design specifications, configuration specifications, Installation Qualification (IQ) protocols, Operational Qualification (OQ) protocols, Performance Qualification (PQ) protocols, User Acceptance Test (UAT) protocols, Data Migration (DM) protocols, Regression Test (RT) protocols including collaboration, approval, oversight, test execution, discrepancy management, and generation of final reports through the use of EDMS and closure of change records via QMS. Additionally, risk assessment of functional requirements is often required. The job requires simultaneous activities for multiple validation deliverables within planned timelines. The job requires representing validation interests on project teams, interacting with hosting vendors, contractors, preparing validation change control request records, and conducting periodic reviews. This is a hybrid position - 3 days/week onsite in the RTP, NC office, and 2 days a week work from home.
- Support validation efforts as an experienced professional with a full understanding of industry practices and company policies and procedures
- Resolve a wide range of issues whether related to specifications, configuration, security role, system response, data, or business process
- Work on problems of diverse scope where analysis of data requires identification of root cause events
- Perform periodic review of computer systems in accordance with schedule
- Determine prospective and regression testing approaches based on a risk assessment process
- Provide general support to the Validation organization to meet department goals and objectives
- Interact professionally with business users and technical experts to provide validation support for in-house managed systems and also systems provided by software as a service (SaaS) vendors or hosting vendors
- Participate on project teams requiring validation support
- Provide training to company and contracted personnel on validation policies and procedures
- Participate in the preparation or review of protocols and reports supporting the validation of equipment, systems and processes
- Develop, execute and summarize the delivery of validation protocols
- Assist team in collecting, compiling and reviewing data in support of validation studies
- Support validation change control activities
- Perform other validation duties as assigned
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) in science, engineering, information technology or information systems
- For Validation Engineer level: 3+ years of relevant validation experience in a pharmaceutical/cGMP environment
- For Senior Validation Engineer level: 5+ years of relevant validation experience in a pharmaceutical/cGMP environment
- Experience performing validation activities for computer system related protocols
- Working knowledge of US and international regulations related to validation activity
- Ability to perform with minimal supervision on assigned tasks and projects
- Detail oriented, self-motivated, organized, and have the ability to prioritize work
- Proficient with MS Office suite for document processing and spreadsheets
- Proficient with Adobe Acrobat for PDF file management
- Knowledgeable of 21 CFR Part 11 for Electronic Records and Electronic Signatures
- Knowledgeable of FDA, MHRA, EMA guidance for Data Integrity and Compliance
- Experience with SAP S/4 HANA upgrades and change management including assessment of regulatory impact, determination of validation deliverables, review of test results, specification management, security role management, WRICEF collaboration and approvals
- Experience with validation and operation of the following: SAP ERP, SAP SuccessFactors, MasterControl, TrackWise, Veeva CTMS, Veeva Clinical, MicroFocus ALM (previously HP Quality Center), Argus, TraceLink, LabWare LIMS, Medidata, DocuSign, Docubridge, and Medical Information Request Management System
- Experience with Data Migration activities including determination of sampling based on ASQ AQL, conducting electronic Source/Target data comparisons, and assisting or performing visual comparison of results
- Knowledge and experience with GAMP5 Risk Based Approach to GxP Computerized Systems and risk assessment method
- Knowledge and experience with GAMP Good Practice IT Infrastructure and Compliance
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
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