Quality Assurance Validation Specialist II

Immatics-US; Houston (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

4 weeks vacation

Holidays

Job summary

Immatics-US in Stafford, TX is seeking a Quality Assurance Validation Specialist II to support Global Quality Operations. You will oversee regulated assets and VLMS, ensuring QMS and GMP compliance, and act as SME in biopharmaceutical quality on-site.

You will review URS, Risk Assessments, Validation Plans, Protocols, and Reports; ensure GDP; collaborate with QA and cross-functional teams; support Data Management, AI, and archival initiatives.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science or related field.
• 3+ years’ experience in a related role in biopharma/regulated setting.
• Advanced understanding of Validation Lifecycle Pillars (IQ/OQ/PQ, CSV, equipment qualification).
• Experience with GxP-regulated automated systems and GDP practices.

Responsibilities

• Review and approve asset validation documentation (URS, Risk Assessments, Validation Plans, Protocols, Validation Reports).
• Review and approve OMC procedures ensuring GDP and quality compliance.
• Serve as QA SME for validation deliverables in GxP systems, equipment, labs and IT infrastructure.
• Provide QA guidance based on industry standards and Cell Therapy practices.
• Collaborate with cross-functional stakeholders to align QA activities across sites and management.

Skills

GxP Validation

QA Validation

GMP Knowledge

GDP Awareness

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science or related

Tools

VLMS

Validation software

Job description

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 OverviewWe 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.Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-siteReports to: Senior Manager, Quality Assurance ValidationLocation: 13203 Murphy Road Suite 100 Stafford, TX 77477Basic Qualifications: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.Preferred Qualifications: Experience in one or more of the following areas: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.In this role you will: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.What do we offer?At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join ImmaticsComprehensive Benefits:Competitive rates for Health, Dental, and Vision Insurance4 weeks of vacation, granted up front each year and prorated for first and last year of employment.12 company paid holidays7 days of sick time100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars100% employer-paid short- and long-Term disability coverage401(k) with immediate eligibility and company match…The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.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.Equal Employment OpportunityWe are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law.Reasonable AccommodationsWe are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us at [e-mail] AuthorizationApplicants must be authorized to work in the United States without the need for current or future sponsorship.Pre-Employment RequirementsEmployment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening, where permitted by applicable law. For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job-related and consistent with business necessity.