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.

Recruitment Transparency Notice



Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.

Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
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About Eliassen Group:

Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.

Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.

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