Validation Engineer II

The Validation Engineer II 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, Operational and Performance Qualification Protocols and Validation Summary Reports. This includes leading and/or supporting validation of processes, equipment, and computer systems. The Validation Engineer II also provides assistance 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.


Requirements

Duties and 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.

Qualifications

• Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred.
• At least 2-5 years of experience in related Engineering 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 Job requires working in-office, must be willing to work weekends and evening hours, as necessary. Must be willing to accommodate travel, as 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.


Disclaimer: Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship.



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.