Validation Engineer III

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company with robust infrastructure and highly skilled teams providing global R&D, clinical, manufacturing, regulatory, and IP capabilities. We are committed to advancing patient care and access to important medicines.

About the role

The Validation Engineer III is a full-time exempt position based in Piscataway, NJ. This role involves developing, testing, modifying, and creating solutions to technical problems within a medical device or FDA-regulated environment.

Responsibilities

• Draft and implement Quality System documentation including SOPs and Traceability Matrix to establish good validation practices.
• Author URS, IQ, OQ, and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Coordinate validation activities with vendors and cross-functional teams, 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 for current and future processing equipment and interface with Contract Manufacturers.
• Lead or participate in deviation/CAPA investigations related to qualification failures, equipment malfunctions, or out-of-specification results using 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.
• Support non-engineering staff, including R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Maintain validation status tracking dashboards and conduct periodic system health reviews to ensure inspection readiness.
• Execute assigned duties on time and proactively communicate delays or issues to the validation manager and stakeholders.
• Comply with all regulatory, corporate, and Quality System policies.

Requirements

• Degree in engineering, Pharmaceuticals, or another relevant discipline.
• 8+ years of experience in a medical device or other FDA-regulated environment; experience with Biological products is highly desirable.
• Specialized knowledge and skills in Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP), and Quality Systems (Change Control, Non-Conformances, Requalification).
• Understanding of cGxP principles and familiarity with ISO guidelines.
• Working knowledge of Computer Systems Validation lifecycle and documentation.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to work independently, multitask, and support multiple projects simultaneously.
• Strong communication, interpersonal, teamwork, technical writing, and presentation skills.

Pay

Base salary range: $70,000 to $90,000, with up to a 10% discretionary yearly cash bonus.

Benefits

• Medical Insurance (Aetna)
• Prescription Converge | Rx and Virtual Visits (Aetna/Teladoc)
• Health Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)
• Dental Insurance (Aetna)
• Vision Insurance (VSP)
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits (Legal Services, ID Theft Protection, Travel Assistance)
• Value Added Benefits & Services (Health Advocate, Life Assistance Program, Student Loan Assistance Program)
• 401K
• Monthly Cell Phone Allowance

Schedule

Onsite 5 days a week, Monday through Friday, from 9:00 AM to 5:30 PM EST.

Working Environment

• Noise: No extraordinary noise levels.
• Standing/Lifting: Must be able to lift at least 25 lbs.
• Visual: No extraordinary requirements.
• Stress: High-paced, demanding environment to meet ambitious project goals.
• Travel: Required as needed, 20%-30%.