Sr. Staff Validation Engineer

Description: The Sr. Staff Validation Engineer ensures the reliability, consistency, and compliance of processes, methods, equipment, and systems to meet regulatory requirements and quality standards. This role is responsible for developing the quality assurance and validation strategy for new process introduction, sustaining product line remediation, maintenance, and improvement/optimization. This role drives the preparation and execution of validation documentation, including Validation Plans, Installation, Operational, and Performance Qualification Protocols and Validation Summary Reports. The Validation Engineer also leads the development and execution of risk assessments in process development as part of new product development or sustaining programs Requirements:

Duties And Responsibilities

• Responsible for new process introduction, sustaining product line remediation, maintenance, and improvement/optimization from a quality assurance and validation strategy standpoint.
• Lead complex tasks or 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, method, system qualifications and process validations. This includes establishing performance criteria, troubleshooting, and ensuring compliance with safety and quality standards.
• Serve as a technical expert in assessing the impact of process, material, or equipment changes on validation status and provide guidance on revalidation or change control measures.
• 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 complex technical problems, and contribute to project milestones.
• Develop and execute process risk assessment (pFMEA) in order to identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively.
• 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.
• Train personnel involved in validation activities and offer expertise and support to other departments on validation-related matters.
• 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.). Familiarity with the design and development of collagen-based scaffolds preferred.
• At least 10 years of experience in related Engineering or Quality role.
• Experience in validations preferred.
• Strong knowledge of FDA 21 CFR 820 regulations and/or FDA 21 CFR 1271. Knowledge of ISO 13485, device cGMP, AATB, and/or cGTP guidelines preferred.
• Knowledge in medical device design controls, risk management principles per ISO 14971, and use of risk assessment tools such as pFMEA preferred.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
• Expertise in manufacturing and process design, with a strong focus on optimizing production workflows, improving efficiency, and ensuring quality control throughout the development lifecycle.
• 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.
• Quality Engineering Certification (ASQ) or equivalent is preferred
• 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)

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.