Validation Specialist (Biotech)

TL;DR

Validation Specialist (Biotech): Supporting the qualification and validation of analytical instruments and equipment in QC and Manufacturing with an accent on compliance and lifecycle documentation. Focus on executing IQ/OQ/PQ protocols, managing deviations, and ensuring adherence to FDA 21 CFR Part 11 and GxP standards.

Location: Must be based in Newark, CA (Onsite)

Salary: $70–$80 per hour

Company

A clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Author and review periodic reviews for analytical instruments, computerized systems, and equipment.
• Manage lifecycle documentation including URS, functional specifications, and qualification protocols.
• Coordinate and approve vendor IQ/OQ/PQ protocols and summary reports.
• Troubleshoot complex protocol deviations and exceptions related to systems and equipment.
• Collaborate with cross-functional stakeholders to ensure compliant operation and maintenance.

Requirements

• Bachelor’s degree in a scientific discipline required.
• 6+ years of experience in qualification and validation within the pharmaceutical industry.
• Extensive experience in Computer System Validation (CSV).
• Strong understanding of FDA 21 CFR Part 11, Part 820, GxP, and GAMP 5.
• Must be authorized to work in the U.S.
• Ability to work onsite in Newark, CA.

Culture & Benefits

• Opportunity to work with a talented team in a collaborative biotechnology environment.
• Focus on developing life-changing products for patients.
• Commitment to a diverse and inclusive workforce.