Senior Facilities Validation Manager

Immatics; Stafford, Northern (TX, KY); Hybrid; USD 130,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Vacation time

Paid holidays

Sick time

Life insurance

Disability insurance

401(k) plan

Parental leave

Voluntary benefits

Job summary

Immatics is seeking a Senior Facilities Validation Manager to lead the Facilities Engineering team in Stafford, TX, ensuring GMP manufacturing equipment, utilities, and facilities are qualified and available for production and lab operations. You will drive IQ/OQ/PQ programs, develop preventive and reliability-centered maintenance, and collaborate with Quality on deviations and change controls.

This role offers comprehensive benefits and opportunities to influence manufacturing readiness for

Qualifications

• Bachelors degree in Mechanical, Electrical, or Chemical Engineering.
• 7+ years in pharmaceutical/biotech with GxP manufacturing.
• 5+ years leading validation/engineering teams.
• Strong knowledge of FDA and cGMP requirements.
• IQ/OQ/PQ experience and exposure to CSV interfaces.

Responsibilities

• Lead validation and qualification of GMP equipment and utilities.
• Oversee IQ, OQ, PQ, and lifecycle management.
• Partner with Quality to manage deviations, CAPAs, and change control.
• Mentor equipment validation and reliability engineers.
• Manage engineering budgets and KPIs.

Skills

GxP experience

Validation leadership

FDA compliance

IQ/OQ/PQ

CSV interfaces

Maintenance planning

Budget management

Team mentoring

Asset lifecycle

Education

Bachelor's degree in Mechanical/Electrical/Chemical Engineering

Tools

CMMS

BMS/EMS

Job description

## Senior Facilities Validation ManagerApply: Houston: Full time: Posted 3 Days Ago: JR100728***Join Immatics and shape the future of cancer immunotherapy; one patient at a time!*** Immatics is 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 TCR bispecifics. **Why Join Us?** * **Innovative Environment:**Help to pioneer advancements in cancer immunotherapy.* **Collaborative Culture:** Be part of a diverse team dedicated to your professional growth.* **Global Impact:**Contribute to therapies that make a lasting impact on patients globally. **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**: 13203 Murphy 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 **Preferred Qualifications:** * 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 this role you will:** * 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?** At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics **Comprehensive Benefits**: * Competitive rates for Health, Dental, and Vision Insurance* 4 weeks of vacation, granted up front each year and prorated for first and last year of employment.* 12 company paid holidays* 7 days of sick time* 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars* 100% employer-paid short- and long-Term disability coverage* 401(k) with immediate eligibility and company match. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.* Partially paid parental leave for eligible employees.* Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.**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 to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, 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 with sincerely held religious 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 must be authorized to work 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, reference checks and pre-employment drug screening, where permitted by applicable law. For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job-related and consistent with business necessity.