Senior Validation Engineer, Equipment (Relocation Assistance Available)

United Therapeutics Corporation; Jacksonville (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics in Jacksonville, FL is seeking a Senior Validation Engineer focused on equipment validation within a biopharma manufacturing environment. The role supports GMP operations and quality systems, and involves validating equipment, systems, and processes.

You will manage validation documentation, investigate issues, and collaborate across QA, manufacturing, and engineering teams. Hybrid work schedule with most days onsite in Jacksonville and opportunities to adapt to business

Qualifications

• Bachelor’s degree in science or engineering.
• 5+ years of validation experience in cGMP/medical device settings.
• Strong knowledge of validation lifecycle and regulatory requirements (FDA, EU).
• Proficient in validation data systems (e.g., Kaye/Ellab) and standard software.
• Excellent communication, organization, and ability to work independently.

Responsibilities

• Develop, review, and execute validation protocols and reports for equipment and systems.
• Support validation lifecycle documentation and change controls.
• Troubleshoot validation issues and perform root cause analysis.
• Assist with audits, regulatory inspections, and quality systems.
• Maintain equipment and asset data; ensure GMP compliance.

Skills

Validation expertise

Regulatory knowledge

Communication skills

Independent work

Education

Bachelor’s in science or engineering

Tools

Kaye/Ellab

PC/office software

BMS/SCADA familiarity

Job description

Senior Validation Engineer specializing in equipment validation within a biopharma manufacturing environment, supporting GMP operations and quality systems.

Responsibilities

• develop, review, and execute validation protocols and reports for equipment, systems, and processes
• support validation lifecycle documentation
• troubleshoot and resolve validation issues
• perform root cause analysis
• support change controls, audits, and regulatory inspections
• maintain equipment and asset data
• ensure compliance with GMP, GLP, and QSR standards

Qualifications

• Bachelor’s in science or engineering
• 5+ years of validation experience in cGMP/medical device setting
• strong knowledge of validation lifecycle, industry standards, and regulatory requirements (FDA, EU)
• proficient in validation data systems (e.g., Kaye/Ellab) and standard software
• excellent communication, organization, and independent work skills

Preferred

• familiarity with computerized systems like BMS, DCS, or SCADA

High-value specifics

• equipment validation for manufacturing/quality activities in a biologics or medical device context, supporting validation documentation, change management, and regulatory readiness

Work setup

hybrid in Jacksonville, FL, with at least four days/week onsite, potential increase to five based on business needs.