Senior Validation Engineer - Medical Devices (Remote)

Scorpion Therapeutics; Jacksonville (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/dental/vision

401k/ESPP

PTO & parental leave

Job summary

Scorpion Therapeutics seeks a senior validation specialist to lead validation programs, develop protocols, and review final reports for asset lifecycle management. You will liaise between Quality and Operations, coordinate validation activities, and support audits with 24/7 data review capabilities.

The role requires a Bachelor's in science or engineering and 5+ years of validation in a cGMP environment, with strong communication, independent working style, and knowledge of FDA/EU GMP

Qualifications

• Bachelor's degree in science or engineering field.
• 5+ years validation experience in medical device/cGMP environment.
• Strong validation lifecycle knowledge with cross-functional skills.
• Detail-oriented, organized; able to work independently.
• Ability to perform/review/oversee equipment qualification.
• Validation datalogger knowledge (Kaye/Ellab preferred).
• Working knowledge of FDA/EU validation/GMP requirements.
• Proficiency with business/technical software and basic statistics.

Responsibilities

• Support full equipment lifecycle by developing, reviewing, and executing validation protocols and final reports.
• Coordinate and serve as technical resource for equipment/system/process validation.
• Develop, execute, and review validation lifecycle documentation (SOPs, VMPs, URS/FRS, etc.).
• Support contracted resources; troubleshoot/resolve validation issues; drive corrective actions.
• Provide validation QA guidance/training; evaluate change control from a validation perspective.
• Participate in internal/regulatory audits; onsite contact for validation services.
• Maintain equipment/asset data; provide real-time review of manufacturing data with 24/7 availability.
• Review Quality System documentation for accuracy/compliance; support investigations and inspections.

Skills

Validation lifecycle

Cross-functional collaboration

Attention to detail

Independent worker

Statistical analysis

Education

Bachelor's degree in science or engineering

Tools

Kaye/Ellab data logger

Blue Mountain RAM

Job description

Scorpion Therapeutics seeks a senior validation specialist to lead validation programs, develop protocols, and review final reports for asset lifecycle management. You will liaise between Quality and Operations, coordinate validation activities, and support audits with 24/7 data review capabilities.

The role requires a Bachelor's in science or engineering and 5+ years of validation in a cGMP environment, with strong communication, independent working style, and knowledge of FDA/EU GMP