Quality Assurance Validation Specialist II

Immatics • Houston, TX

10d • Onsite

About The Position

Join Immatics and shape the future of cancer immunotherapy; one patient at a time! Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Why Join Us?
Innovative Environment: Help to pioneer advancements in cancer immunotherapy.
Collaborative Culture: Be part of a diverse team dedicated to your professional growth.
Global Impact: Contribute to therapies that make a lasting impact on patients globally.

Role Overview
We are seeking a Quality Assurance Validation Specialist II to support our Global Quality Operations team. The QA Validation Specialist II will be responsible for providing QA oversight of regulated assets and business processes within the Validation Lifecycle Management System (VLMS), ensuring compliance with the Quality Management System (QMS) and GMP requirements. This role will also serve as a Subject Matter Expert (SME) in biopharmaceutical quality and as an on-site QA representative within the U.S. QA Validation team.

Requirements

• Bachelor Degree in Engineering, Life Sciences, Computer Science or related.
• At least three years’ experience in a related role.
• Possess scientific, technical background with experience in Biotechnology, Engineering, Computer Science or related field as well as work experience in related Biopharma industry or similar regulated settings.
• Advanced understanding of Validation Lifecycle Pillars, which may include equipment lifecycle management, equipment qualification execution, equipment operation, equipment maintenance, workflows incl. GxP Computerized System Validation (CSV), Qualification phases such as IQ, OQ, PQ, Manufacturing Process Validation and Continued Process Verification.

Nice To Haves

• Quality Assurance (QA) validation within a regulated biopharmaceutical environment.
• QA release activities within regulated environments.
• Regulatory audits and inspections.
• Development, review, and contribution to documentation supporting the testing, validation, and release of Quality Control (QC) and production equipment within clinical and/or commercial GMP environments.
• Cell and Gene Therapy operations, including clinical and/or commercial-stage environments.
• Software application deployment, administration, and periodic review within regulated environments.
• Analytical method validation.

Responsibilities

• Review and approve asset validation documentation, including User Requirement Specifications (URS), Risk Assessments, Validation Plans, Qualification Protocols, and Validation Reports.
• Review and approve operational, maintenance, and cleaning (OMC) procedures, ensuring compliance with quality requirements and Good Documentation Practices (GDP).
• Ensure compliance with applicable regulations and the company’s Quality Management System (QMS).
• Serve as the QA representative for validation deliverables related to GxP-regulated computerized systems, production equipment, laboratory methods, facilities, and IT infrastructure.
• Provide QA guidance and best practices based on industry standards and current Cell Therapy practices, including Adoptive Cell Therapy.
• Collaborate with cross-functional stakeholders to align QA Validation activities with U.S. QA Validation Management, Global Quality Operations, and Site Leadership.
• Provide QA support for Data Management, Digitalization, Artificial Intelligence (AI), Operational Excellence, Business Continuity, and Archival initiatives.

Benefits

• Competitive rates for Health, Dental, and Vision Insurance
• 4 weeks of vacation, granted up front each year and prorated for first and last year of employment.
• 12 company paid holidays
• 7 days of sick time
• 100% employer-paid life insurance up to 1x annual salary, up to one hundred thousand dollars
• 100% employer-paid short- and long-Term disability coverage
• 401(k) with immediate eligibility and company match
• Partially paid parental leave for eligible employees.
• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level