Commissioning/Validation Specialist - Apex, NC

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

• Location 56 Hunter Street,Suite 330,Apex, NC, 27502,United States
• Base Pay $70,000.00 - $105,000.00 / Year

Description

We currently have an opening for a Commissioning, Qualification & Validation (CQV) Specialist in our Apex, NC office serving pharmaceutical, biotechnology, and life sciences clients. As part of a multidisciplinary team, 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. You will also coordinate with engineering, construction, quality, operations, vendors, and client representatives to resolve issues and support system turnover.

Requirements

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline, or equivalent relevant industry experience.
• 0 to 5 yrs of experience in commissioning, qualification, validation, engineering, or a 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.

Summary

A pre-employment drug screening and background check are required.

Hallam-ICS is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.