Lead GMP Facilities Validation Engineer

Eliassen Group; Clayton (NC); On-site; USD 83,000 - 96,000; Full time

Job summary

Eliassen Group is seeking an experienced Facilities and Utilities Validation Engineer to lead qualification activities for GMP facility modifications, building systems, critical utilities and supporting infrastructure in Clayton, NC. The consultant will support multiple projects and coordinate cross-functionally with Engineering, Facilities, Maintenance, Automation, Quality, vendors and project management.

W2 role with a benefits package including medical, dental, vision, 401k with company

Qualifications

• Hands-on qualification experience with GMP facilities or utilities.
• Experience with HVAC, BMS, process instrumentation, monitoring, calibration, electrical distribution, controls or similar systems.
• Demonstrated protocol authorship and field execution experience.
• Knowledge of GMP, FDA expectations, EU Annex 15, commissioning and change control.

Responsibilities

• Develop system boundaries, criticality assessments, requirements, validation plans, risk assessments, protocols, traceability matrices and reports.
• Lead Design Qualification, commissioning reviews, IQ, OQ, and PQ for facility and utility systems.
• Review drawings, specifications, control narratives, alarm lists, calibration records, vendor packages and turnover documentation.
• Verify operating ranges, alarms, interlocks, monitoring, controls, instrumentation and utility performance.
• Document and resolve deviations, support change controls and assess validation impact.
• Maintain compliant electronic records and communicate schedule, risks and escalations to project managers.

Skills

GMP Facilities

HVAC Systems

BMS

Process Instrumentation

Calibration

Electrical Distribution

Validation Protocols

Change Control

FDA Knowledge

EU Annex 15

Tools

Veeva

TIMS/HP ALM

Job description

Eliassen Group is seeking an experienced Facilities and Utilities Validation Engineer to lead qualification activities for GMP facility modifications, building systems, critical utilities and supporting infrastructure in Clayton, NC. The consultant will support multiple projects and coordinate cross-functionally with Engineering, Facilities, Maintenance, Automation, Quality, vendors and project management.

W2 role with a benefits package including medical, dental, vision, 401k with company