Validation Engineer II — GMP/GxP Compliance (On-Site)

Immatics; Georgia; On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health Insurance

Vacation 4 weeks

Holidays

Life Insurance

Disability coverage

401(k) with company match

Parental leave

Dental & Vision

Employee assistance program

Job summary

Immatics is seeking a Validation Engineer II to lead the validation of new systems and ensure all regulatory requirements are met. The role will build and run a periodic review program for validated systems, ensuring compliant documentation and traceability.

The position is on-site in Stafford, TX, reports to the Senior Director, Enterprise Applications, and requires 5+ years in pharma/biotech with GxP knowledge.

Qualifications

• Bachelor’s degree in Science, Engineering or related major; Biotechnology-related preferred.
• 5+ years experience in pharmaceutical or biotech industry.

Responsibilities

• Draft validation documents including validation plans, URS, risk assessments, IQ/OQ/PQ protocols, trace matrices and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols with proper documentation.
• Create and manage project timelines and deliverables.
• Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) to ensure compliance.
• Contribute to writing, coordination, review and approval of Quality Events.
• Coordinate, support, and investigate CAPAs.
• Draft SOPs and work instructions for system operation, maintenance, and cleaning.
• Assist in Change Control processes from initiation to training and implementation.
• Assist in preparing QMS training materials and perform training as required.
• Support cross-functional groups for QMS functions and projects, including audits.
• Perform periodic reviews, requalifications and remediations for systems.

Skills

GxP experience

Regulatory compliance

Documentation practices

Education

Bachelor's degree in Science/Engineering

Tools

Documentation tools (TrackWise)

IQ/OQ/PQ documentation

Job description

Immatics is seeking a Validation Engineer II to lead the validation of new systems and ensure all regulatory requirements are met. The role will build and run a periodic review program for validated systems, ensuring compliant documentation and traceability.

The position is on-site in Stafford, TX, reports to the Senior Director, Enterprise Applications, and requires 5+ years in pharma/biotech with GxP knowledge.