Validation Engineer II

JoinImmaticsandshape thefuture ofcancerimmunotherapy; one patient at atime!

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 Validation Engineer II to lead the implementation of new systems through the validation process and ensure all validation deliverables and regulations have been met. The Validation Engineer II will build and execute a periodic review program for our validated systems.

Schedule: 8:00 AM 5:00 PM; Monday to Friday; On-site
Reports to:Senior Director Enterprise Applications
Location: 13203Murphy Road Suite 100 Stafford TX 77477

Basic Qualifications:

• Bachelors degree in Science Engineering or a related in Biotechnology or a related major preferred

• 5 years experience in the pharmaceutical or biotech industry

PreferredQualifications:

• Experience working within a GxP regulated manufacturing or laboratory environment.

• An understanding of good documentation practices and data integrity principles.

• Demonstrated understanding of 21 CFR Part 11 21 CFR Part 210 21 CFR Part 211 GAMP 5 and USP

• Experience in writing and reviewing deviations and CAPAs investigations leading to change controls

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) and Batch Record Issuance procedures 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 system 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 Computer Systems Validation Equipment Maintenance Manufacturing Quality Control New Hire Onboarding external and internal audits as needed.

• Perform periodic reviews requalifications and remediations for systems throughout the system lifecycle.

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 weeksofvacationgrantedup front each year and prorated for firstand lastyearofemployment.

• 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.

• Additionalvoluntaryemployee-paidbenefitsandservicesincludingaccidenthospitalindemnityandcriticalillnessinsuranceas well asidentitytheftprotectionandpetinsurance.

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 torace color religion sex (including pregnancy childbirth or related medical conditions) sexualorientation gender identity or expression national origin ancestry age marital status disability geneticinformation 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 withsincerely heldreligious beliefs practices or observances. If you require assistance or accommodation during the application or interview process please contact us at.

Work Authorization

Applicants mustbe authorized towork 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 referencechecksand pre-employment drug screening wherepermittedby applicable law. For certain rolesadditionalscreenings such as a credit check or motor vehicle record review may berequired where job-related and consistent with business necessity.