Validation Engineer III

Company Overview

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Position Summary

The Validation Engineer III is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This employee will be responsible for developing, testing, modifying, and creating solutions to technical problems.

Essential Duties & Responsibilities:

• Draft and implement Quality System documentation including SOPs and Traceability Matrix designed to establish good validation practices within the organization.
• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Coordinate all validation activities with vendors, cross functional team and assemble results, and draft validation reports.
• Serve as the validation representative during FDA, customer, and internal audits.
• Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.
• Lead or participate in deviation/CAPA investigations related to qualification failures, equipment malfunctions, or out-of-specification results, applying root cause analysis methodologies (5-Whys, Ishikawa, Fault Tree).
• Prepare, Review and approve vendor qualification documentation, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) protocols and execution reports.
• Develop and maintain the site Validation Master Plan (VMP), including validation impact assessments, criticality ranking, and lifecycle change management for validated systems.
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Maintain validation status tracking dashboards and periodic system health reviews to ensure all validated systems remain in a continuous state of inspection readiness.
• Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies.