Vivex Biologics · 1 month ago
Validation Engineer II
Miami,FL,US
Full-time
Onsite
Entry, Mid Level
2+ years expVivex Biologics is a company focused on ensuring the reliability and compliance of processes and systems within the biologics field. The Validation Engineer II plays a crucial role in preparing and executing validation documentation, leading validation projects, and ensuring compliance with regulatory standards.
BiotechnologyHealth CareTherapeutics
Responsibilities
Perform critical review of Validation Engineer I project plans and related documents to ensure implementation is accurate and timely
Independently lead and coordinate cross-functional projects and related resources to ensure completion in a timely manner. Communicate to management of performance against project plan
Perform data and technical presentation reviews as needed
Lead specific tasks or larger projects and ensure their successful completion, with minimal oversight
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 validation-related guidance, solve technical problems, and contribute to project milestones
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
Ensure personal and company compliance with all federal, state, company and regulatory bodies’ regulations, policies, and procedures
Other duties as assigned
Qualification
Required
Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.)
At least 2-5 years of experience in related Engineering role
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 change
Preferred
Proficiency in microbiology
Experience in validations
Strong knowledge of FDA, AATB, and cGTP guidelines
Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry
Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs)
Project management skills
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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