Facilities Engineer II

immatics; Houston (TX); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Vacation 4 weeks/year

Holidays 12 days/year

Sick time 7 days/year

Life insurance 100% employer-paid

Disability coverage

401(k) with company match

Job summary

Immatics is hiring a Facilities Engineer II to lead asset validation and qualification efforts, support cGMP manufacturing and GxP operations, and manage facility projects. The role includes drafting validation protocols, executing IQ/OQ/PQ tests, and coordinating CAPAs and changes.

Located at 13203 Murphy Road, Stafford, TX, the position offers a Monday–Friday schedule with some on-call support. A strong background in biotech/biopharma engineering and FDA/cGMP knowledge is required.

Qualifications

• 5+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or laboratory environment.
• Knowledge of FDA and cGMP requirements.
• Experience with 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, and change controls for QMS.

Responsibilities

• Draft validation documents including validation plans, URS, risk assessments, configuration specs, IQ/OQ/PQ protocols, trace matrix and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols with good documentation practices and provide supporting evidence.
• Create and manage project timelines and deliverables.
• Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) to ensure compliance with regulatory requirements.
• Coordinate, support, and investigate CAPAs.
• Draft SOPs and work instructions for asset operation, maintenance and cleaning.
• Assist in Change Control processes and training implementations.
• Support cross-functional groups for QMS functions and asset validation, equipment maintenance, manufacturing, QA, audits.

Education

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

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 advances 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 reli