Senior Facilities Validation Manager

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 Senior Facilities Validation Manager to lead the Facilities Engineering team responsible for ensuring GMP manufacturing equipment utilities and facility assets are qualified and validated reliable and available for production and lab operations ready for Phase III manufacturing and commercial launch and continuously improved using reliability engineering principles. This role bridges Facilities Validation CMC Manufacturing CSV and Quality (OQA QAV).

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 Mechanical Electrical Chemical Engineering or related field

• 7 years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or laboratory environment with 5 of those years directly leading teams

PreferredQualifications:

• Strong knowledge of FDA and cGMP requirements

• Deep experience with IQ/OQ/PQ with exposure to CSV interfaces

• Expertise in cleanrooms and critical utilities

• Experience supporting commercial biologics or cell therapy manufacturing

• Familiarity with CMMS BMS/EMS digital maintenance systems

• PMP or similar certification is advantageous

• Demonstrated 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:

• Lead validation and qualification of GMP manufacturing equipment process utilities HVAC systems cleanrooms compressed gases etc.

• Oversee IQ OQ PQ Requalification strategy and Validation lifecycle management.

• Develop and manage preventive maintenance predictive maintenance reliability-centered maintenance asset criticality analysis and equipment lifecycle planning to maximize equipment uptime reduce unplanned downtime and improve overall equipment effectiveness.

• Support transition from late-stage clinical manufacturing to commercial operations

• Partner with Quality to manage deviations lead equipment investigations execute CAPAs and support change control.

• Lead mentor and coach equipment validation engineers and reliability engineers.

• Manage engineering budgets and KPIs.

• Perform engineering duties when necessary

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.