Facilities Engineer II

Immatics; Stafford, Northern (TX, KY); Hybrid; USD 110,000 - 125,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

4 weeks vacation

12 company paid holidays

Life insurance

Short- and long-term disability

401(k) with company match

Job summary

Immatics is seeking a Facilities Engineer II to lead asset validation and requalification efforts, supporting cGMP Manufacturing and GxP operations with equipment issues. You will manage facility projects, develop validation documents, and ensure regulatory compliance at the Stafford, TX site.

Ideal candidates have a 4- to 6-year track record in pharma/biotech engineering, solid GxP knowledge, and experience with deviations, CAPAs, and change controls to sustain a compliant quality system.

Qualifications

• Bachelor's degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field.
• 5+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or lab setting.
• Preferred: knowledge of FDA and cGMP requirements.
• Understanding of 21 CFR Part 11, 210, 211, EU Annex 1, and USP guidelines.
• Experience writing/reviewing Deviations and CAPAs; handling investigations (OOS/OOT, environmental excursions) and Change Controls.

Responsibilities

• Draft validation documents and protocols (IQ/OQ/PQ), trace matrices, and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols with proper documentation.
• Create and manage project timelines and deliverables.
• Monitor CAPA, Change Controls, and Deviations to ensure regulatory compliance.
• Assist in QMS training, SOPs, and audit support.

Skills

GxP compliance

CAPA handling

Deviations investigations

Education

Bachelor's degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field

Job description

## Facilities Engineer IIApply: Houston: Full time: Posted 30+ Days Ago: JR100727***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 **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 needed**Reports to**: Director, Facilities, Engineering, & Asset Lifecycle **Location**: 13203 Murphy Road Suite 100 Stafford, TX 77477 **Basic Qualifications:** * Bachelors degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field* 5+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or laboratory environment **Preferred Qualifications:** * Demonstrated knowledge of FDA and cGMP requirements* Applied 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 USP* Experience 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 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 insurance up to at 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. 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 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 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 Accommodations**We 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]. **Work Authorization** Applicants must be authorized to work 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, 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.