Facilities Engineer II: Lead Asset Validation & Compliance

Immatics; Georgia; On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health Insurance

Vacation 4 weeks

Company Holidays

Sick time 7 days

Life Insurance 100% employer-paid

Disability insurance

Job summary

Immatics is seeking a Facilities Engineer II to drive asset validation and qualification for cGMP manufacturing and QA-aligned support. The role involves leading validation deliverables, supporting equipment issues, and managing facility projects.

You will draft IQ/OQ/PQ protocols, oversee risk assessments, and ensure regulatory compliance. The position schedules 8:00 am–5:00 pm, Monday–Friday, with on-call as needed.

Qualifications

• Bachelor's degree required in a related engineering field.
• 5+ years in pharma/biotech engineering within a GxP environment.
• Familiarity with FDA and cGMP requirements and good documentation practices.

Responsibilities

• Draft validation documents (IQ/OQ/PQ, validation plans, URS, risk assessments, configuration specs).
• Execute test scripts from IQ/OQ/PQ with proper documentation.
• Create and manage project timelines and deliverables.
• Monitor Quality Management Systems (CAPA, Change Controls, Deviations) for compliance.
• Coordinate and investigate CAPAs; support writing and approval of Quality Events.
• Assist in Change Control processes and training.
• Prepare QMS training materials and deliver training as required.
• Support cross-functional groups for Asset Validation, Equipment Maintenance, Manufacturing, Quality Control, and audits.

Skills

GxP knowledge

FDA basics

Documentation practices

Data integrity

Education

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

Job description

Immatics is seeking a Facilities Engineer II to drive asset validation and qualification for cGMP manufacturing and QA-aligned support. The role involves leading validation deliverables, supporting equipment issues, and managing facility projects.

You will draft IQ/OQ/PQ protocols, oversee risk assessments, and ensure regulatory compliance. The position schedules 8:00 am–5:00 pm, Monday–Friday, with on-call as needed.