Facilities Engineer II

Join Immatics and help shape the future of cancer immunotherapy—one patient at a time. 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.

About the role

We are seeking a Facilities Engineer II to lead the implementation of new assets through the validation process and/or requalifying assets to ensure all validation deliverables and regulations have been met. You will technically support cGMP Manufacturing and GxP operations with equipment issues and manage facility projects as necessary.

Location: 13203 Murphy Road Suite 100, Stafford, TX 77477
Schedule: Monday to Friday, 8:00 am – 5:00 pm; on-call support as needed

Responsibilities

• 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 the 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, including Asset Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and internal audits as needed.

Requirements

• Bachelor’s degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or a 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.
• 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.

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 1x annual salary, up to $100,000.
• 100% employer-paid short- and long-term disability coverage.
• 401(k) with immediate eligibility and company match (100% match up to 3% of base salary for the first two years, 4% for years 2-3, and up to 5% from the fourth year onward).
• 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.