CQV Engineer (Raleigh)

TRC Talent Solutions is partnering with a leading engineering and project delivery organization to identify a CQV Engineer to support major capital projects within the life sciences, biotech, pharmaceutical, food & beverage, and advanced technology sectors. This is a project-based role requiring significant travel to client sites nationwide. Travel accommodations and per diem are provided.

Position Overview
The CQV Engineer will be responsible for the commissioning, qualification, and validation of critical facilities, utilities, equipment, and systems in regulated environments. This individual will work closely with cross-functional teams to ensure systems are designed, installed, tested, and documented in compliance with cGMP, FDA, EU, and industry standards.
Key Responsibilities

• Develop, execute, and document commissioning and qualification protocols including IQ, OQ, and PQ.
• Support the development of CQV plans, risk assessments, and traceability matrices.
• Perform commissioning activities such as system walkdowns, equipment testing, troubleshooting, and turnover support.
• Participate in and support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Collaborate with project managers, engineers, automation teams, and clients to deliver CQV scope on schedule and within project requirements.
• Interface with automation and controls systems including Allen Bradley, Siemens, and DeltaV PLCs/DCS.
• Author detailed reports, deviations, change controls, and final qualification turnover packages.
• Ensure compliance with cGMP, FDA, EMA, and applicable regulatory and industry best practices.
• Provide technical CQV support during design, construction, start-up, and handover phases.

Qualifications

• Bachelors degree in Engineering (Mechanical, Electrical, Chemical, or related discipline) or equivalent relevant experience.
• Minimum of 3 years of hands-on commissioning, qualification, and validation experience in life sciences, biotech, or pharmaceutical environments.
• Practical experience with automation platforms such as Allen Bradley, Siemens, and/or DeltaV.
• Working knowledge of FDA, EMA, and ICH guidelines related to CQV activities.
• Strong technical problem-solving skills with the ability to work independently in fast-paced, project-driven environments.
• Excellent written and verbal communication skills with strong attention to detail in documentation.
• Willingness and ability to travel extensively on a project basis; per diem and lodging provided.

Company Description:
TRC Talent Solutions is proud to be an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law. At TRC, we take pride in fulfilling our opportunity to add value to our client's business as their staffing partner, while working tirelessly to connect thousands of individuals each year with work opportunities where they can meet the needs of their families and have the potential to build their careers.