Validation Lead

TechnoSphere, Inc.; New Jersey; Hybrid; USD 90,000 - 130,000; Full time

Job summary

TechnoSphere, Inc. is seeking a seasoned Computer System Validation (CSV) professional for pharma/biotech/medical device environments. The role requires 3+ years of CSV experience, with focus on M&A data migration, infrastructure qualification in data platforms, and adherence to FDA/GxP, GAMP, and SDLC guidelines.

Strong leadership and communication skills are essential. Hybrid work arrangement in the Raritan, NJ area with eligible candidates from the NJ/NY corridor.

Qualifications

• 3+ years of Computer System Validation (CSV)
• FDA & GxP regulations
• Risk-Based Validation
• GAMP
• SDLC
• QA, UAT & Traceability Matrix
• Strong communication and leadership skills
• Must Have - CSV experience in M&A data migration and related infrastructure qualification in data Platform domain
• Pharma / Biotech / Medical Device experience

Responsibilities

• Ensure CSV compliance for pharma/biotech/medical device projects.
• Lead QA, UAT and maintain Traceability Matrix.
• Apply risk-based validation methodologies per GAMP and SDLC.
• Coordinate data migration efforts and infrastructure qualification in data platform domains.
• Communicate effectively with stakeholders and provide leadership.

Skills

CSV validation

GxP

FDA

Risk-based validation

M&A data migration

Data platform

Leadership

Communication

Job description

Location: Raritan, #NJ OR #NY – (#Hybrid)

Time Zone: #EST candidates can apply

Visa: H1B Level 2/3 only

Must Have:

Must Have - Computer System Validation experience M&A related Data Migration and related infrastructure qualification in data Platform domain

#Pharma / #Biotech / #Medical Device experience

3+ years of Computer System Validation (CSV)

FDA & GxP regulations

Risk-Based Validation

GAMP

SDLC

QA, UAT & Traceability Matrix

Strong communication and leadership skills