CQV Specialist — Pharma/Biotech Field Validation

Hallam-ICS; Apex (NC); On-site; USD 70,000 - 105,000; Full time

Job summary

Hallam-ICS is seeking a Commissioning, Qualification & Validation (CQV) Specialist for our Apex, NC office. You will review engineering and equipment documentation, verify installation and operation of facilities, utilities, equipment, and process support systems, and develop and execute commissioning and qualification documents.

As part of a multidisciplinary team, you will coordinate with engineering, construction, quality, operations, vendors, and client representatives to resolve issues and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• 0–5 years of experience in commissioning, qualification, validation, engineering, or related technical role.
• Strong technical writing skills and documentation skills.
• Strong communication, collaboration, self-management, and attention to detail in a client-facing, regulated environment.
• Ability to interpret engineering drawings, specifications, P&IDs, submittals, and equipment documentation.
• Experience with field verification, functional testing, protocol execution, and resolution of deficiencies or deviations.
• Knowledge of cGMP principles and the qualification lifecycle, including IQ/OQ/PQ or commissioning protocols, preferred.
• Experience with HVAC, utilities, controlled environments, process equipment, automation, or building management systems preferred.
• Ability to travel to client sites as required.

Responsibilities

• Review engineering and equipment documentation.
• Verify installation and operation of facilities, utilities, equipment, and process support systems.
• Develop and execute commissioning and qualification documents.
• Coordinate with engineering, construction, quality, operations, vendors, and client representatives to resolve issues and support turnover.
• Support system turnover and client handover.

Skills

Technical writing

Communication

Attention to detail

Client-facing

Collaboration

Self-management

Education

Bachelor's degree in Engineering, Life Sciences, or related

Job description

Hallam-ICS is seeking a Commissioning, Qualification & Validation (CQV) Specialist for our Apex, NC office. You will review engineering and equipment documentation, verify installation and operation of facilities, utilities, equipment, and process support systems, and develop and execute commissioning and qualification documents.

As part of a multidisciplinary team, you will coordinate with engineering, construction, quality, operations, vendors, and client representatives to resolve issues and