QA Validation Specialist II — Biotech GMP

Immatics; Stafford, Northern (TX, KY); Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health, Dental, Vision

401(k) with match

Life insurance

Disability insurance

Paid time off

Parental leave

Job summary

Immatics seeks a Quality Assurance Validation Specialist II to support the Global Quality Operations team on-site in Stafford, TX. You will oversee validation activities for regulated assets and processes within VLMS, ensuring adherence to QMS and GDP in a biopharma setting.

The role requires a bachelor’s degree and 3+ years of related experience, with SME capabilities in CSV, IQ/OQ/PQ, and GxP environments. Join a collaborative, growth-focused culture with comprehensive benefits.

Qualifications

• Bachelor degree in Engineering, Life Sciences, Computer Science or related.
• At least three years’ experience in a related role.
• Advanced understanding of Validation Lifecycle Pillars and CSV (GxP).
• Experience in biopharma or regulated settings.

Responsibilities

• Review and approve asset validation documentation (URS, Risk Assessments, Validation Plans, Protocols and Reports).
• Review and approve OMC procedures ensuring GDP compliance.
• Ensure compliance with QMS and applicable regulations.
• Serve as QA representative for validation deliverables across GxP-regulated systems, equipment, lab methods, facilities, and IT infrastructure.
• Provide QA guidance for Cell Therapy practices and collaborate with cross-functional teams.

Skills

QA validation

CSV (GxP)

IQ/OQ/PQ

GDP knowledge

Regulatory audits

Education

Bachelor Degree in Engineering, Life Sciences, Computer Science or related

Tools

VLMS

QMS

Job description

Immatics seeks a Quality Assurance Validation Specialist II to support the Global Quality Operations team on-site in Stafford, TX. You will oversee validation activities for regulated assets and processes within VLMS, ensuring adherence to QMS and GDP in a biopharma setting.

The role requires a bachelor’s degree and 3+ years of related experience, with SME capabilities in CSV, IQ/OQ/PQ, and GxP environments. Join a collaborative, growth-focused culture with comprehensive benefits.