Senior Validation Engineer — Lead GMP Validation in Life Sciences

GBA Team

Broomfield (CO)

On-site

USD 145,000 - 150,000

Full time

2 days ago

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Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid holidays & PTO

Job summary

GBA Team is seeking a Senior/Project Lead Validation Engineer to provide technical leadership in commissioning, qualification, and validation within regulated life sciences environments. You will develop validation strategies and lifecycle deliverables, mentor staff, and coordinate with manufacturing, QA, and project teams on complex projects.

The role requires 5–10 years of GMP experience, SME status in validation, and deep knowledge of regulatory expectations (GMP/ISPE).

Qualifications

Bachelor’s degree in life sciences or related field.
5–10 years GMP experience.
Experience with validation principles, lifecycle deliverables, and regulatory expectations.

Responsibilities

Lead and oversee commissioning, qualification, and validation activities for facilities, equipment, systems, and processes.
Develop and execute validation lifecycle documentation (URS, IQ/OQ/PQ, FAT/SAT, reports) and risk-based strategies.
Provide technical leadership across projects from greenfield to upgrades and product development.
Mentor validation specialists and interface with clients, regulators, and cross-functional teams.