Facilities Engineer II

Immatics-US; Houston (TX); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Health, Dental, Vision Insurance

Vacation & Holidays

401(k) with company match

Life Insurance

Job summary

Immatics-US is seeking a Facilities Engineer II to lead asset validation through IQ/OQ/PQ, provide technical support for cGMP manufacturing and GxP operations, and manage facility projects. The role requires documentation discipline, CAPA handling, and Change Control participation.

Located at 13203 Murphy Road, Stafford, TX, the position reports to the Director of Facilities, Engineering, & Asset Lifecycle, and offers comprehensive benefits and on-site work hours with potential on-call support.

Qualifications

• Bachelors in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field.
• 5+ years in pharmaceutical/biotech engineering within a GxPregulated environment.
• Knowledge of FDA/cGMP requirements and data integrity principles.
• Experience in writing/ reviewing Deviations and CAPAs and investigations.

Responsibilities

• Draft validation documents: validation plans, URS, risk assessments, IQ/OQ/PQ protocols, trace matrices, reports.
• Execute test scripts from IQ/OQ/PQ and provide evidence per documentation standards.
• Create and manage project timelines and deliverables.
• Monitor QMS: CAPA, Change Controls, Deviations for regulatory compliance.
• Coordinate/prepare Quality Events and CAPA investigations as needed.
• Draft SOPs and work instructions for asset operation, maintenance, and cleaning.
• Assist in Change Control processes through doc revisions and training.
• Support cross-functional QMS projects and audits.

Skills

GxP experience

Regulatory compliance knowledge

Documentation best practices

CAPAs & Deviations handling

Project management

Education

Bachelors in Biotechnology/Engineering

Tools

Validation protocols

QA/QMS systems

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 Facilities Engineer II to lead the implementation of new assets through the validation process and/or requalifying assets ensure all validation deliverables and regulations have been met, technically support cGMP Manufacturing and GxP operations with equipment issues, and manage Facility projects, as necessary.Schedule: Monday to Friday; 8:00 am – 5:00 pm; on-call support as neededReports to: Director, Facilities, Engineering, & Asset LifecycleLocation: 13203 Murphy Road Suite 100 Stafford, TX 77477Basic Qualifications:Bachelors degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field5+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or laboratory environmentPreferred Qualifications:Demonstrated knowledge of FDA and cGMP requirementsApplied experience in good documentation practices and data integrity principles.An understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, EU Annex 1, and USPExperience in writing and reviewing Deviations and CAPAs, investigations resulting from OOS/OOT, environmental excursions, lab investigations leading to Change Controls for QMS.In 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) 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 asset 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 Asset Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and internal audits as needed.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.