Senior Quality Validation Engineer II
Company: VIVEX BIOLOGICS INC
Location: Miami
Posted on: February 15, 2026
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Job Description:
Job Description Job Description Description: 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
review of validation documentation, including Validation Plans,
User Requirements Specifications, Installation and Operational
Qualification Protocol, Performance Qualification Protocols and
Validation Summary Reports and ensuring that these are compliant
with the regulations and/or standards. This includes supporting
validation of processes, equipment, cleaning, and computer systems.
The Quality Validation Engineer also provides assistance and
mentorship to system owners and Validation Engineers with impact
risk assessments to identify the qualification and validation
requirements, on equipment before returning or handing over to the
system owner and assist in arranging external services when
required. Requirements: Duties and 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. Qualifications 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. Experience in
validations preferred. Strong knowledge of ISO 13845, 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 changes. Experience working
with peptides a plus 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)
Nothing in this job description restricts management’s right to
assign or reassign duties and responsibilities to this job at any
time. Vivex Biologics, Inc. is an equal opportunity employer (EEO)
and expressly prohibits any form of workplace discrimination and/or
harassment based on race, color, religion, gender, sexual
orientation, gender identity or expression, national origin, age,
genetic information, disability, or veteran status. This policy
applies to all terms and conditions of employment, including
recruiting, hiring, placement, promotion, termination, layoff,
transfers, leaves of absence, compensation, and training. Vivex
Biologics, Inc. complies with the Americans with Disability Act
(ADA) which prohibits discrimination against qualified individuals
with disabilities who, with or without reasonable accommodation,
can perform the essential functions of a job.
Keywords: VIVEX BIOLOGICS INC, Pembroke Pines , Senior Quality Validation Engineer II, Engineering , Miami, Florida
