Facilities Engineer II

Immaticsis committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting ofPRAME a target expressed in more than 50 cancers. Ourcutting-edgescience and robust clinical pipeline form the broadestPRAMEfranchise with the mostPRAMEindications and modalities spanning TCR T-cell therapies and TCRbispecifics.

Why Join Us

• Innovative Environment:Helptopioneeradvancementsincancer immunotherapy.

• Collaborative Culture:Be part ofa diverse team dedicated to yourprofessionalgrowth.

• Global Impact:Contribute to therapiesthatmakealastingimpactonpatientsglobally.

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: 13203Murphy 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

PreferredQualifications:

• 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 thisrole youwill:

• 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

AtImmatics we believe in investing in our teams healthsafetyand you can expectif youjoinImmatics

Comprehensive Benefits:

• Competitive rates forHealth Dental and Vision Insurance

• 4 weeks ofvacationgranted up front each year and prorated for firstand lastyear ofemployment.

• 12 company paid holidays

• 7daysof sick time

• 100%employer-paidlifeinsuranceup toat 1x annual salary up to one hundred thousand dollars

• 100%employer-paidshort- andlong-Termdisabilitycoverage

• 401(k) withimmediateeligibilityandcompany match. The company will match100% of your contributions upto3% of yourbase salaryfor the first two yearsof employment 4% foryears 2-3 of employment and up to5%of your salaryfrom the fourth year onward of continued employment.

• Partiallypaidparentalleavefor eligible employees.

• Additionalvoluntary employee-paidbenefits and servicesincludingaccidenthospitalindemnity andcriticalillnessinsurance as well as identitytheftprotection andpetinsurance.