Validation Engineer - Facilities and Utilities

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.
  

Education Requirements