Senior Quality Engineer

United Therapeutics Corporation•Jacksonville, FL

21d•Hybrid

About The Position

United Therapeutics (Nasdaq: UTHR) is a public benefit corporation dedicated to developing novel pharmaceutical therapies and technologies for rare, deadly diseases and to address the shortage of transplantable organs. Founded in 1996, the company has six FDA-approved therapies for conditions like pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma. Their pipeline includes treatments for PAH and pulmonary fibrosis (PF). United Therapeutics is also working on creating manufactured organs to eliminate transplant waiting lists. The company is described as bold, unconventional, and focused on innovation for unmet medical needs.

Requirements

Bachelor’s Degree in science or engineering field
5+ years of relevant validation experience in a medical device/cGMP environment
Solid understanding of validation lifecycle principles, industry best practices, and internal policies and procedures
Strong written and verbal communication skills, with the ability to effectively collaborate cross-functionally and communicate validation status, technical information, and data to peers, management, and stakeholders
Highly detail-oriented, self-motivated, and organized, with the ability to prioritize and manage multiple tasks and projects effectively
Demonstrated ability to work independently with minimal supervision and adapt to changing priorities in a dynamic environment
Ability to perform, review, and oversee equipment qualification activities
Working knowledge of applicable regulatory requirements, including FDA and EU guidelines related to validation and GMP activities
Proficiency in standard business and technical software, including word processing, spreadsheets, email systems, and basic statistical tools

Nice To Haves

Working knowledge of validation datalogger systems (Kaye/Ellab preferred). Proficiency preferred
Working knowledge of systems, including computerized information systems, manufacturing control systems (e.g., BMS, DCS, and SCADA systems)

Responsibilities

Performs activities supporting the full equipment lifecycle.
Develops, reviews, and executes validation protocols and final reports.
Represents Validation/Quality Engineering on cross-functional project teams.
Prepares and assesses validation-related change control requests.
Develops, and/or assists in developing, validation plans, requirements specifications, protocols and final reports.
Serves as a liaison between Quality and the Operations Asset Management team to support asset lifecycle management requirements and ensure alignment with regulatory and quality standards.
Applies extensive knowledge and skills in equipment validation to support validation activities and maintain a full understanding of validation principles and practices.
Coordinates validation activities and serves as a technical resource within assigned areas of validation.
Develops, executes, reviews, and supports approval of validation protocols and reports for equipment, systems, and processes, providing technical input during document preparation and review.
Collects, compiles, analyzes, and interprets validation data to confirm and maintain the validated state of equipment for GMP use, working independently with review at critical points.
Develops, executes, and reviews validation lifecycle documentation, including but not limited to SOPs, Validation Master Plans (VMPs), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications, FAT/SAT, and DQ/IQ/OQ/PQ/PV protocols and reports.
Supports contracted resources by providing direction on validation activities and reviewing documentation for compliance with established requirements.
Troubleshoots and resolves equipment, system, and process issues using established procedures and sound technical judgment, escalating more complex issues as needed.
Performs root cause analysis and applies appropriate problem-solving methodologies to address issues of varying scope.
Conducts gap assessments of validation documentation, systems, and practices, communicates findings, and supports implementation of corrective actions and process improvements.
Provides technical guidance and training on validation policies, procedures, and practices to internal and contracted personnel.
Supports departmental operational goals by providing validation and quality engineering support as needed.
Evaluates and supports change control activities from a validation perspective, including authoring or reviewing change assessments.
Participates in internal and regulatory audits by providing validation support and contributing to audit readiness activities.
Serves as an onsite point of contact for contracted validation services for assigned activities.
Maintains equipment and asset data within the Blue Mountain RAM system in alignment with asset lifecycle management requirements.
Provides real-time review of manufacturing and service data.
Reviews Quality System documentation (analytical/medical records, batch records, protocols, reports, environmental monitoring data, Device Design History Files, laboratory data, etc.) for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and GMP/GLP/QSR and internal requirements.
Works to get record/documentation corrections and spearheads efforts for continuous improvement.
Provides QA guidance, when needed to internal partners.
Performs raw material review/inspection and release.
Works with internal and external partners to identify areas of improvement and follows through to project completion.
Coordinates controlled document collaboration, review, and approval.
Detects quality system gaps and coordinates resolution.
Performs quality assurance activities to ensure compliance with current regulatory standards (e.g. deviation/failure investigations, change control documentation management, complaints, standard operating procedures, product quality review).
Identifies organizational need for document/system updates and coordinates the review, creation/update of SOPs and reports to support these systems.
Assists Operations, Quality, and R&D in the preparation of validation protocols and reports.
Coordinates validation plans and tasks to assure timely completion of validation projects, as assigned.
Assists management during FDA or other regulatory agency inspections.
Supports the timely and accurate transfer of data, documents, and information to inspectors.
Responsible for maintaining Quality System files (electronic and physical) including training records, protocols/reports, EM data, cleaning records, decontamination records.