Quality Assurance Validation Specialist II

Immatics; Houston (TX); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Vacation (4 weeks)

Paid holidays (12)

Sick time (7 days)

Life insurance

Disability insurance

401(k) with company match

Parental leave

Additional voluntary benefits

Job summary

Immatics is a leader in precision cancer immunotherapy and seeks a QA Validation Specialist II to oversee regulated assets within VLMS and ensure GMP compliance. The role is on-site in Stafford, TX, reporting to the Senior Manager, Quality Assurance Validation.

Candidates should have a Bachelor’s in a related field and 3+ years in a regulated biopharma environment, with expertise in CSV, GDP, and validation lifecycle pillars.

Qualifications

• Bachelor level degree in engineering, life sciences, CS, or related field.
• Experience in regulated biopharma environments and validation.
• Solid understanding of Validation Lifecycle Pillars and IQ/OQ/PQ processes.

Responsibilities

• Review and approve asset validation documentation (URS, Risk Assessments, Validation Plans, Protocols, Validation Reports).
• Approve OMC procedures ensuring GDP compliance.
• Ensure compliance with QMS and GMP requirements; act as SME for validation deliverables.

Skills

QA oversight

GxP understanding

Regulatory audits experience

Education

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

Tools

VLMS (Validation Lifecycle Management System)

GDP (Good Documentation Practices)

CSV (GxP Computerized System Validation)

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 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.

Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-site

Reports to: Senior Manager, Quality Assurance Validation

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

Basic 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 Immatics

Comprehensive 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 insuranceup to at 1x annual salary, up to one hundred thousand dollars
• 100% employer-paid short- and long-Term disability coverage
• 401(k) with immediate eligibilityand 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 leavefor 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 Opportunity

We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard torace, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexualorientation, gender identity or expression, national origin, ancestry, age, marital status, disability, geneticinformation, veteran status, or any other status protected by applicable law.

Reasonable Accommodations

We are committed to providing reasonable accommodations to individuals with disabilities and to applicants withsincerely heldreligious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us [e-mail].

Work Authorization

Applicants mustbe authorized towork in the United States without the need for current or future sponsorship.

Pre-Employment Requirements

Employment is contingent upon successful completion of a background check, referencechecksand pre-employment drug screening, wherepermittedby applicable law. For certain roles,additionalscreenings such as a credit check or motor vehicle record review may berequired, where job-related and consistent with business necessity.