Senior Facilities Validation Lead for GMP Biotech Ops

Immatics

Stafford, Northern (TX, KY)

Hybrid

USD 130,000 - 170,000

Full time

12 days ago
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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

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

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