Senior Validation Engineer: Lead GMP Projects & QA

GBA Team

Milwaukee (WI)

On-site

USD 110,000 - 150,000

Full time

3 days ago

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Benefits offered by this job

Medical, dental, and vision insurance

Life, accident, disability coverage

401(k) with company match

EAP and wellness initiatives

Paid holidays & flexible time off

Job summary

GBA is seeking a Senior Validation Engineer to lead commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, and processes in regulated life sciences environments. You will develop lifecycle documentation and provide technical leadership across multiple projects.

This role requires 5–10 years GMP experience, a life sciences degree, strong written communication, and SME capability in validation.

Qualifications

Bachelor’s degree in a related life sciences or equivalent training.
5–10 years GMP experience.
Subject Matter Expert (SME) in validation area.
Proficient with GMP and regulatory requirements.
Excellent written communication skills.

Responsibilities

Lead and support commissioning, qualification, and validation activities for facilities, utilities, equipment, systems, cleaning, and manufacturing processes.
Develop lifecycle documentation: plans, protocols, tests, reports, and related documentation.
Provide technical leadership throughout all project phases: greenfield, renovations, installation, development, launches, upgrades.
Review documentation for alignment with validation requirements and regulatory expectations.
Coordinate protocol execution with manufacturing, facilities, quality, and project stakeholders.
Mentor validation specialists and engineers; act as SME in validation or regulatory compliance.