Role Overview We are seeking a
Senior Facilities Engineering 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 Engineering, 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.
