Senior Validation Engineer - Equipment

California, US residentsclick here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

The Senior Validation Engineer, Equipment (LBE) 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.

• 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.
• 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

Minimum 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

Preferred Qualifications

• Working knowledge of systems, including computerized information systems, manufacturing control systems (e.g., BMS, DCS, and SCADA systems)

Job Location

This role is based in our Jacksonville, FL office. Currently this job is a hybrid role requiring at least four days per week in the office. In office requirements could increase to five days per week based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.