Senior GMP Validation Engineer – CQV & Commissioning

strivepharmacy; Florida; On-site; USD 105,000 - 115,000; Full time

Job summary

Strive Pharmacy in Alachua, FL is seeking a Validation Engineer III to manage end-to-end validation documentation in a GMP facility, bridging operations, validation, and project delivery.

The role requires strong technical validation expertise, experience with commissioning/qualification, and compliance with global regulatory standards; on-site Monday to Friday is expected in a clean GMP environment.

Qualifications

• BS in Chemical, Mechanical, or Bio-engineering.
• 10+ years in engineering/validation within GMP settings.
• Experience with CQV lifecycle and 21 CFR Part 11.

Responsibilities

• Engineering commissioning: develop and review P&IDs, PFDs, and mass/energy balances.
• GMP compliance & validation: own Validation Master Plan and QA-led changes.
• Documentation execution: write IQ/OQ/PQ protocols and risk assessments.
• Vendor/documentation: assess vendor validation packages and gap analyses.
• Turn-key handover: coordinate with Metrology for CMMS onboarding.

Job description

Strive Pharmacy in Alachua, FL is seeking a Validation Engineer III to manage end-to-end validation documentation in a GMP facility, bridging operations, validation, and project delivery.

The role requires strong technical validation expertise, experience with commissioning/qualification, and compliance with global regulatory standards; on-site Monday to Friday is expected in a clean GMP environment.