Senior Validation Engineer I

3 months ago

Doral, United States VIVEX BIOLOGICS INC Full time

Description Job purpose The Validation Engineer ensures the reliability, consistency, and compliance of our processes, equipment, and systems to meet regulatory requirements and quality standards. This role mainly drives the preparation and execution of validation documentation, including User Requirements Specifications, Installation and Operational Qualification Protocol, Performance Qualification Protocols and Validation Summary Reports. This includes leading and/or supporting validation of processes, equipment, cleaning, and computer systems. The Validation Engineer also provides assistance and mentorship to system owners with impact risk assessments to identify the qualification and validation requirements, carrying out validation activities on equipment before returning or handing over to the system owner, and assist in arranging external services when required. Duties and responsibilities Lead specific tasks or larger projects and ensure their successful completion, independently. Develop and execute validation plans for both new and existing processes, equipment, and systems. Generate and execute qualification protocols to perform equipment qualifications and process validations. This includes establishing performance criteria, equipment troubleshooting, and ensuring compliance with safety and quality standards. Support company’s Master Validation Plan (MVP) including commissioning activities and protocols executions and establishing re-validation criteria. Collaborate with cross-functional teams to provide Quality-related guidance, solve technical problems, and contribute to project milestones. Conduct data analysis and make recommendations to ensure tissue safety/quality and compliance with standards. Conduct trending analysis of relevant Quality metrics to recommend initiatives for improvement and/or corrective actions, as applicable. Assess the impact of process, material, or equipment changes on validation status and provide guidance on revalidation or change control measures. Identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively. Train personnel involved in validation activities and offer expertise and support to other departments on validation-related matters. Support compliance investigations and recommend corrective and preventive actions, as needed. Ensure personal and company compliance with all federal, state, company and regulatory bodies’ regulations, policies, and procedures. Mentor and guide other engineers, fostering their technical growth and professional development. Requirements Qualifications Bachelor’s degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred. At least 4-5 years of experience in related Engineering or Quality role. Experience in validations preferred. Strong knowledge of FDA, AATB, and cGTP guidelines preferred. Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry. Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs) preferred. Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint). Effective oral, written, communication, and presentation skills. Strong analytical and problem-solving skills. Project management skills preferred. Ability to be assertive and influence others and lead significant change. Working conditions Must be willing to accommodate travel if necessary. Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards. Physical requirements While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds. Direct reports No direct reports (Individual contributor role)

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