Validation Engineer III

Description

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.

Requirements

Position Requirements and Qualifications

Minimum Qualifications:

Education:

• ·Degree in engineering / Pharmaceuticals or another relevant discipline.

Experience:

• 8+ years of experience working within a medical device environment or other FDA-regulated environments.
• Experience with Biological products is highly desirable.

Preferred Qualifications:

SPECIALIZED KNOWLEDGE AND SKILLS:

• Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), Understanding of cGxP principles and familiarization with ISO guidelines.
• Working knowledge of Computer Systems Validation lifecycle and documentation.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Must be able to work independently with adequate supervision, multitask, and support several projects simultaneously.
• Must demonstrate strong communication, interpersonal and teamwork skills.
• A strong understanding of technical writing and presentation skills is required.

Compensation:

• Validation Engineer III - Base Salary Range and Yearly Bonus - $70,000 to $90,000 (dependent on years of experience and fit for the position) with up to a yearly 10% (discretionary) cash bonus

Benefits/Perks:

• Medical Insurance - Aetna
  • Prescription Converge | Rx
  • 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 (LAP)
  • Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance

Hours:

This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• 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%

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.