Validation Engineer II

Immatics; Georgia; On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health Insurance

Vacation 4 weeks

Holidays

Life Insurance

Disability coverage

401(k) with company match

Parental leave

Dental & Vision

Employee assistance program

Job summary

Immatics is seeking a Validation Engineer II to lead the validation of new systems and ensure all regulatory requirements are met. The role will build and run a periodic review program for validated systems, ensuring compliant documentation and traceability.

The position is on-site in Stafford, TX, reports to the Senior Director, Enterprise Applications, and requires 5+ years in pharma/biotech with GxP knowledge.

Qualifications

• Bachelor’s degree in Science, Engineering or related major; Biotechnology-related preferred.
• 5+ years experience in pharmaceutical or biotech industry.

Responsibilities

• Draft validation documents including validation plans, URS, risk assessments, IQ/OQ/PQ protocols, trace matrices and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols with proper documentation.
• Create and manage project timelines and deliverables.
• Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) to ensure compliance.
• Contribute to writing, coordination, review and approval of Quality Events.
• Coordinate, support, and investigate CAPAs.
• Draft SOPs and work instructions for system operation, maintenance, and cleaning.
• Assist in Change Control processes from initiation 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 audits.
• Perform periodic reviews, requalifications and remediations for systems.

Skills

GxP experience

Regulatory compliance

Documentation practices

Education

Bachelor's degree in Science/Engineering

Tools

Documentation tools (TrackWise)

IQ/OQ/PQ documentation

Job description

_ 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 of PRAME , a target expressed in more than 50 cancers. Ourcutting-edgescience and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications 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

• 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

Preferred Qualifications

• 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 this role you will:

• 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 team’s health,safetyand well-being.Here’swhat you can expectif youjoinImmatics

Comprehensive Benefits

• Competitive rates forHealth, 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 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-paidbenefitsandservices,includingaccident,hospitalindemnity,andcriticalillnessinsurance,as 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 [e-mail].

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 roles,additionalscreenings such as a credit check or motor vehicle record review may berequired, where job-related and consistent with business necessity.