Vivex Biologics · 6 hours ago
Senior Quality Validation Engineer II
Miami,FL,US
Full-time
Onsite
Senior Level
5+ years expVivex Biologics is focused on ensuring the reliability and compliance of processes and systems in the biologics industry. The Senior Quality Validation Engineer II is responsible for reviewing validation documentation, supporting validation processes, and mentoring other engineers to maintain quality standards and regulatory compliance.
BiotechnologyHealth CareTherapeutics
Responsibilities
Review and approve validation plans for both new and existing processes, equipment, and systems
Review and approve qualification protocols for equipment qualifications and process validations and subsequent reports. This includes ensuring that the performance criteria, are compliant with safety and quality standards
Work with the Validation Engineers to troubleshoot any issues and/or deviations encountered during the execution of the protocol
Support company’s Master Validation Plan (MVP) and performing periodic reviews to ensure that it still aligns with the current regulations and the Validation Program requirements
Conduct periodic reviews and updates of the Validation Program for compliance with applicable regulations and standards
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
Work with the Validation Engineers to assess the impact of process, material, or equipment changes on validation status and provide guidance on revalidation or change control measures
Work with the Validation Engineers to identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively
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
Qualification
Required
Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred
At least 5-6 years of experience in related Engineering or Quality role
Strong knowledge of ISO 13845, FDA, AATB, and cGTP guidelines
Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry
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
Ability to be assertive and influence others and lead significant changes
Preferred
Experience in validations
Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs)
Project management skills
Experience working with peptides
Company
Vivex Biologics
VIVEX Biologics' mission is to provide regenerative product solutions that help patients suffering from musculoskeletal injuries and wounds.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chris Agle
President & COO Legacy Donor Services Foundation
Tim Ganey
Chief Science Officer
Recent News
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