Senior Validation Engineer III – GMP/CSV Expert

Kashiv BioSciences, LLC; Newtown (NJ); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life and AD&D Insurance

Disability Benefits

401K

Monthly Cell Phone Allowance

Job summary

Kashiv BioSciences, LLC in Piscataway, NJ is seeking a Validation Engineer III to develop, test, and implement validation solutions in a regulated environment. You will draft protocols, coordinate with vendors, and support technology transfer while maintaining compliance.

The role emphasizes validation systems, QC documentation, and collaboration with R&D and manufacturing teams to ensure inspection readiness and continuous improvement.

Qualifications

• Degree in engineering or pharmaceuticals or another relevant discipline.
• 8+ years in a medical device environment or FDA-regulated setting.
• Biological products experience is highly desirable.
• Specialized knowledge of validation, quality systems, and cGxP.

Responsibilities

• Draft and implement Quality System documentation including SOPs and Traceability Matrix.
• Author URS, IQ, OQ, PQ protocols and execute them per GDP guidelines.
• Coordinate validation activities with vendors and cross-functional teams.
• Lead or participate in deviations and CAPA investigations.
• Develop and maintain the Validation Master Plan and related docs.

Skills

Communication skills

Technical writing

Presentation skills

Independent work

Multi-project multitasking

Education

Engineering or pharmaceutical degree

Tools

Microsoft Word

MS Excel

PowerPoint

Job description

Kashiv BioSciences, LLC in Piscataway, NJ is seeking a Validation Engineer III to develop, test, and implement validation solutions in a regulated environment. You will draft protocols, coordinate with vendors, and support technology transfer while maintaining compliance.

The role emphasizes validation systems, QC documentation, and collaboration with R&D and manufacturing teams to ensure inspection readiness and continuous improvement.