Validation Engineer – Facilities and Utilities

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

On-site in Clayton, NC

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

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Rate: $60.00 to $70.00/hr. w2

Responsibilities:

• Develop system boundaries, criticality assessments, requirements, validation plans, risk assessments, protocols, traceability matrices, and reports.
• Lead Design Qualification, commissioning review, IQ, OQ, and PQ activities 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.

Experience Requirements:

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

Preferred Experience

• Cleanrooms, controlled environments, critical utilities, environmental monitoring interfaces, or facility expansion and shutdown projects.
• Electronic validation systems such as Veeva or TIMS/HP ALM.