Validation Engineer II

_ Join Immaticsandshape 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 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 TCRbispecifics.

• Innovative Environment: Helptopioneeradvancementsincancer immunotherapy.

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

• Global Impact: Contribute to therapiesthatmakealastingimpactonpatientsglobally.

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.

8:00 AM – 5:00 PM;
Monday to Friday;
On-site

Senior Director, Enterprise Applications

13203

Murphy Road Suite 100 Stafford, TX 77477

• Bachelor’s degree in Science, Engineering or a related major.
  
  Education in Biotechnology or a related major preferred

• 5+ years experience in the pharmaceutical or biotech industry

• 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

• 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.

AtImmatics, we believe in investing in our team’s health,safetyand well-being.

Here’swhat you can expectif youjoinImmatics

• Competitive rates for Health, Dental, and Vision Insurance

• 4 weeksofvacation,grantedup 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…