Senior Quality Engineer

United Therapeutics•Jacksonville, FL

1d•Hybrid

About The Position

The Senior Quality Control Engineer performs activities supporting the full equipment lifecycle. This role directly supports Manufacturing, Quality Control, and Quality Assurance functions by developing, reviewing, and executing validation protocols and final reports. This role represents Validation/Quality Engineering on cross-functional project teams and is responsible for preparing and assessing validation-related change control requests. Key responsibilities also include developing, and/or assist in developing, validation plans, requirements specifications, protocols and final reports. Additionally, this role 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. 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 Other duties as assigned

Requirements

Bachelor’s Degree in science or engineering field and 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 validation datalogger systems (Kaye/Ellab preferred). Proficiency preferred
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)

Responsibilities

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
Develop, execute, review, and support approval of validation protocols and reports for equipment, systems, and processes, providing technical input during document preparation and review
Collect, compile, analyze, and interpret validation data to confirm and maintain the validated state of equipment for GMP use, working independently with review at critical points
Develop, execute, and review 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
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, escalating more complex issues as needed
Perform root cause analysis and apply appropriate problem-solving methodologies to address issues of varying scope
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
Perform other duties as assigned
Provide real-time review of manufacturing and service data. Requires periodic, scheduled 24/7 availability for procedure/data review (which can be done remotely)
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.