Senior Quality Engineer (Relocation Assistance Available)
United Therapeutics Corporation
August 14, 2026
Remote friendly (Jacksonville, FL)
United States
Operations
Responsibilities:
- Support full equipment lifecycle by developing, reviewing, and executing validation protocols and final reports; provide technical input and liaison between Quality and Operations Asset Management for asset lifecycle management.
- Coordinate and serve as technical resource for equipment/system/process validation; collect/analyze validation data to confirm validated GMP state.
- Develop, execute, and review validation lifecycle documentation (e.g., SOPs, VMPs, URS/FRS, design specs, FAT/SAT, DQ/IQ/OQ/PQ/PV protocols/reports).
- Support contracted resources; troubleshoot/resolution of equipment/system/process issues; perform root cause analysis and gap assessments; drive corrective actions/process improvements.
- Provide validation QA guidance/training; evaluate/support change control from a validation perspective.
- Participate in internal/regulatory audits; serve as onsite point of contact for contracted validation services.
- Maintain equipment/asset data (Blue Mountain RAM); provide real-time review of manufacturing/service data with periodic scheduled 24/7 availability (remote allowed).
- Review Quality System documentation for accuracy/compliance; support investigations, document management, complaints, SOP/product quality review; support inspection readiness and data/document transfer.
Minimum Requirements:
- Bachelor’s degree in science or engineering field.
- 5+ years validation experience in medical device/cGMP environment.
- Strong validation lifecycle knowledge; communication and cross-functional collaboration 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.
Preferred:
- Knowledge of computerized/manufacturing control systems (BMS, DCS, SCADA).
Benefits:
- Eligible employees may participate in medical/dental/vision, wellness resources, 401k/ESPP, paid time off/paid parental leave, disability benefits, and more.
- Support full equipment lifecycle by developing, reviewing, and executing validation protocols and final reports; provide technical input and liaison between Quality and Operations Asset Management for asset lifecycle management.
- Coordinate and serve as technical resource for equipment/system/process validation; collect/analyze validation data to confirm validated GMP state.
- Develop, execute, and review validation lifecycle documentation (e.g., SOPs, VMPs, URS/FRS, design specs, FAT/SAT, DQ/IQ/OQ/PQ/PV protocols/reports).
- Support contracted resources; troubleshoot/resolution of equipment/system/process issues; perform root cause analysis and gap assessments; drive corrective actions/process improvements.
- Provide validation QA guidance/training; evaluate/support change control from a validation perspective.
- Participate in internal/regulatory audits; serve as onsite point of contact for contracted validation services.
- Maintain equipment/asset data (Blue Mountain RAM); provide real-time review of manufacturing/service data with periodic scheduled 24/7 availability (remote allowed).
- Review Quality System documentation for accuracy/compliance; support investigations, document management, complaints, SOP/product quality review; support inspection readiness and data/document transfer.
Minimum Requirements:
- Bachelor’s degree in science or engineering field.
- 5+ years validation experience in medical device/cGMP environment.
- Strong validation lifecycle knowledge; communication and cross-functional collaboration 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.
Preferred:
- Knowledge of computerized/manufacturing control systems (BMS, DCS, SCADA).
Benefits:
- Eligible employees may participate in medical/dental/vision, wellness resources, 401k/ESPP, paid time off/paid parental leave, disability benefits, and more.