Sr. Validation Specialist II

Description Job purpose The Senior Validation Specialist 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 and Operational Qualification Protocol, Performance Qualification Protocols and Validation Summary Reports. This includes leading and/or supporting validation of processes, equipment, cleaning, and computer systems. The Senior Validation Specialist II also provides assistance and mentorship 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. Duties and responsibilities Lead validation activities for new and existing processes, equipment, systems, and manufacturing changes, ensuring timely and successful completion. Independently own validation deliverables required by the organization, including planning, execution, documentation, and closure of assigned activities. Develop, author, execute, and maintain validation plans, protocols, reports, and related documentation in accordance with regulatory and internal requirements. Generate and execute qualification protocols for equipment, utilities, and systems, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as applicable. Support and maintain the company's Master Validation Plan (MVP), including commissioning activities, protocol execution, and establishment of revalidation requirements. Mentor junior engineers and ensure proper execution of validation related activities. Perform impact assessments for process, material, equipment, facility, and system changes to determine validation requirements and revalidation needs. Establish acceptance criteria and evaluate validation results to ensure processes and systems perform as intended and remain in a validated state. Troubleshoot validation-related issues, identify root causes, and implement practical solutions to support operational continuity and compliance. Collaborate with cross-functional teams, including Operations, R D, Quality, Regulatory, and Technical Operations, to support project goals and validation readiness. Analyze validation and operational data to identify trends, assess process performance, and recommend improvements or corrective actions. Identify and assess risks associated with validation activities and manufacturing processes, and implement mitigation measures as appropriate. Support deviation, nonconformance, change control, and investigation activities by assessing validation impact and recommending corrective and preventive actions. Provide technical guidance and training to personnel involved in validation activities and support departments on validation-related requirements and best practices. Review and assess validation-related documentation prepared by others to ensure technical accuracy, completeness, and compliance. Ensure compliance with all applicable federal, state, company, and regulatory requirements, policies, and procedures. Perform other duties as assigned. Requirements Qualifications Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred. At least 10 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. 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. 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 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.