GMP Facilities Engineer II - Validation & Asset Lifecycle

Immatics; Stafford, Northern (TX, KY); Hybrid; USD 110,000 - 125,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

4 weeks vacation

12 company paid holidays

Life insurance

Short- and long-term disability

401(k) with company match

Job summary

Immatics is seeking a Facilities Engineer II to lead asset validation and requalification efforts, supporting cGMP Manufacturing and GxP operations with equipment issues. You will manage facility projects, develop validation documents, and ensure regulatory compliance at the Stafford, TX site.

Ideal candidates have a 4- to 6-year track record in pharma/biotech engineering, solid GxP knowledge, and experience with deviations, CAPAs, and change controls to sustain a compliant quality system.

Qualifications

• Bachelor's degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field.
• 5+ years in pharmaceutical or biotech engineering within a GxP regulated manufacturing or lab setting.
• Preferred: knowledge of FDA and cGMP requirements.
• Understanding of 21 CFR Part 11, 210, 211, EU Annex 1, and USP guidelines.
• Experience writing/reviewing Deviations and CAPAs; handling investigations (OOS/OOT, environmental excursions) and Change Controls.

Responsibilities

• Draft validation documents and protocols (IQ/OQ/PQ), trace matrices, and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols with proper documentation.
• Create and manage project timelines and deliverables.
• Monitor CAPA, Change Controls, and Deviations to ensure regulatory compliance.
• Assist in QMS training, SOPs, and audit support.

Skills

GxP compliance

CAPA handling

Deviations investigations

Education

Bachelor's degree in Biotechnology, Mechanical, Electrical, Chemical Engineering, or related field

Job description

Immatics is seeking a Facilities Engineer II to lead asset validation and requalification efforts, supporting cGMP Manufacturing and GxP operations with equipment issues. You will manage facility projects, develop validation documents, and ensure regulatory compliance at the Stafford, TX site.

Ideal candidates have a 4- to 6-year track record in pharma/biotech engineering, solid GxP knowledge, and experience with deviations, CAPAs, and change controls to sustain a compliant quality system.