Validation Engineer III

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

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

• 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.

• 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

• Medical Insurance - Aetna Prescription Converge | Rx Virtual Visits - Aetna/Teladoc Health Savings Accounts (HSA) Flexible Spending Accounts (FSA)
• Prescription Converge | Rx

• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits Legal Services ID Theft Protection Travel Assistance
• Legal Services

• Travel Assistance
• Value Added Benefits & Services Health Advocate Life Assistance Program (LAP) Student Loan Assistance Program
• Health Advocate

• 401K

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

• 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.