Senior Validation Engineer, Equipment (Relocation Assistance Available)

United Therapeutics Corporation•Jacksonville, FL

7d•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. The company has six FDA-approved therapies and is working on developing additional treatments for pulmonary fibrosis and other conditions. They are also focused on creating manufactured organs to eliminate transplant waiting lists. The Senior Validation Engineer, Equipment (LBE) plays a crucial role in supporting the full equipment lifecycle within Manufacturing, Quality Control, and Quality Assurance functions. This position involves developing, reviewing, and executing validation protocols and reports, representing Validation/Quality Engineering on project teams, and managing validation-related change control requests. The role also involves assisting in the development of validation plans and specifications, and acting as a liaison between Quality and the Operations Asset Management team to ensure compliance with regulatory and quality standards.

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

Responsibilities

Perform activities supporting the full equipment lifecycle.
Develop, review, and execute validation protocols and final reports for equipment, systems, and processes.
Represent Validation/Quality Engineering on cross-functional project teams.
Prepare and assess validation-related change control requests.
Develop validation plans, requirements specifications, protocols, and final reports.
Serve 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.
Apply extensive knowledge and skills in equipment validation to support validation activities and maintain a full understanding of validation principles and practices.
Coordinate validation activities and serve as a technical resource within assigned areas of validation.
Collect, compile, analyze, and interpret validation data to confirm and maintain the validated state of equipment for GMP use.
Develop, execute, and review validation lifecycle documentation, including 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.
Support contracted resources by providing direction on validation activities and reviewing documentation for compliance with established requirements.
Troubleshoot and resolve equipment, system, and process issues using established procedures and sound technical judgment.
Perform root cause analysis and apply appropriate problem-solving methodologies to address issues.
Conduct gap assessments of validation documentation, systems, and practices, communicate findings, and support implementation of corrective actions and process improvements.
Provide technical guidance and training on validation policies, procedures, and practices to internal and contracted personnel.
Support departmental operational goals by providing validation and quality engineering support as needed.
Evaluate and support change control activities from a validation perspective, including authoring or reviewing change assessments.
Participate in internal and regulatory audits by providing validation support and contributing to audit readiness activities.
Serve as an onsite point of contact for contracted validation services for assigned activities.
Maintain equipment and asset data within the Blue Mountain RAM system in alignment with asset lifecycle management requirements.
Provide real-time review of manufacturing and service data.
Review 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.
Work to get record/documentation corrections and spearhead efforts for continuous improvement.
Provide QA guidance, when needed to internal partners.
Perform raw material review/inspection and release.
Work with internal and external partners to identify areas of improvement and follow through to project completion.
Coordinate controlled document collaboration, review, and approval.
Detect quality system gaps and coordinate resolution.
Perform 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).
Identify organizational need for document/system updates and coordinate the review, creation/update of SOPs and reports to support these systems.
Assist Operations, Quality, and R&D in the preparation of validation protocols and reports.
Coordinate validation plans and tasks to assure timely completion of validation projects, as assigned.
Assist management during FDA or other regulatory agency inspections.
Support 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.