Validation Engineer II

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

Benefits offered by this job

Comprehensive Benefits

Vacation time

Company holidays

Life insurance

401(k) with company match

Parental leave

Job summary

Immatics US in Stafford, Texas, is seeking a Validation Engineer II to lead the implementation of new systems and ensure validation deliverables meet regulatory requirements. You will draft validation documents, execute IQ/OQ/PQ tests, and manage timelines.

The role requires 5+ years in pharma/biotech, experience with GxP, 21 CFR parts, and CAPAs. On-site work with a comprehensive benefits package and opportunities for professional growth.

Qualifications

• Bachelor’s degree in Science or Engineering; 5+ years in pharma/biotech preferred.
• Experience within a GxP regulated manufacturing or laboratory environment.
• Strong understanding of 21 CFR Part 11, Part 210, Part 211, GAMP 5 and USP.
• Experience drafting and reviewing deviations and CAPAs, investigations leading to change controls.

Responsibilities

• Draft validation documents: validation plans, URS, risk assessments, IQ/OQ/PQ protocols, trace matrices, and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols with strong documentation practices.
• Create and manage project timelines and deliverables.
• Monitor Quality Management Systems (CAPA, Change Controls, Deviations) for compliance.
• Coordinate and support CAPAs and change controls; assist in training and SOP development.

Skills

GxP experience

Documentation practices

CAPA investigations

Validation testing

IQ/OQ/PQ protocols

Change control support

Education

Bachelor’s degree in Science or Engineering

Tools

Quality Management System (QMS)

Configuration & traceability tools

Validation tooling

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 Validation Engineer II to lead the implementation of new systems through the validation process and ensure all validation deliverables and regulations have been met. The Validation Engineer II will build and execute a periodic review program for our validated systems.Schedule: 8:00 AM – 5:00 PM; Monday to Friday; On-siteReports to: Senior Director, Enterprise ApplicationsLocation: 13203 Murphy Road Suite 100 Stafford, TX 77477Basic Qualifications:Bachelor’s degree in Science, Engineering or a related major. Education in Biotechnology or a related major preferred5+ years experience in the pharmaceutical or biotech industryPreferred Qualifications:Experience working within a GxP regulated manufacturing or laboratory environment.An understanding of good documentation practices and data integrity principles.Demonstrated understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, GAMP 5 and USPExperience in writing and reviewing deviations and CAPAs, investigations leading to change controlsIn this role you will:Draft validation documents including validation plans, user requirements specification (URS), risk assessments, configuration specification documents, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, trace matrix and summary reports.Execute test scripts from IQ/OQ/PQ protocols using good documentation practices and provide appropriate supporting evidence.Create and manage project timelines and deliverables.Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) and Batch Record Issuance procedures to ensure and maintain compliance with corporate and regulatory agency requirements.Contribute to the writing, coordination, review, and approval of Quality Events when needed.Coordinate, support, and investigate Corrective and Preventive Actions (CAPAs).Draft SOPs and work instructions for system operation, maintenance, and cleaning.Assist in Change Control process from initiation, revision of documents and processes up to training and implementation.Assist in preparing QMS training materials and perform training as required.Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and internal audits as needed.Perform periodic reviews, requalifications and remediations for systems throughout the system lifecycle.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.