Senior Commissioning & Qualification (C&Q) Engineer

Job Title: Senior Commissioning & Qualification (C&Q) Engineer HVAC / Cleanroom Systems

Location: Durham, NC Onsite

Employment Type: Contract (W2)

Job Summary

Seeking a Senior C&Q Engineer to troubleshoot, correct, and qualify a redundant rooftop air handling unit (AHU) supporting six production AHUs in Grade C and Grade D cleanroom areas. The role focuses on root cause investigation of an automatic failover issue, corrective action verification, and qualification of HVAC systems for GMP manufacturing.

Responsibilities

• Investigate AHU fan failures, VFDs, wiring, controls, alarms, and automatic failover logic.
• Analyze building automation trends, alarms, and PI Historian data.
• Verify corrective actions and perform post-change functional testing.
• Review and update HVAC, mechanical, electrical, and control system drawings.
• Develop and execute IOV protocols, including failover, alarm, interlock, and VFD fault testing.
• Manage deviations, non-conformances, and CAPA documentation.
• Prepare qualification reports, traceability matrices, operating procedures, and turnover packages.
• Support cleanroom performance verification, including differential pressure, temperature, humidity, and particle count testing.
• Provide project status reports and support ongoing failover testing and change controls.

Requirements

• 7+ years of C&Q experience in GMP-regulated pharmaceutical, biopharma, cell and gene therapy, or sterile manufacturing environments.
• Hands-on experience qualifying HVAC/AHU systems serving classified cleanrooms.
• Knowledge of pressure cascades, differential pressure control, and building automation systems.
• Experience with IQ/OQ or IOV protocols, deviations, non-conformances, and qualification reports.
• Strong troubleshooting skills with VFDs, motors, dampers, and fan systems.
• Knowledge of ISPE Baseline Guide Vol. 5, ASTM E2500, EU GMP Annex 1, and ISO 14644.
• Bachelor's degree in Mechanical, Chemical, or Electrical Engineering, or equivalent experience.
• Strong technical documentation and stakeholder management skills.

Preferred Qualifications

• Experience with Johnson Controls Metasys, PI Historian, Veeva Vault, BMRAM, or plant SCADA.
• Previous experience troubleshooting redundant AHU failover systems.
• Familiarity with TAB reports and NEBB/AABC standards.
• Experience reviewing control system software changes.
• PE, CQE, CCP, or similar professional certification.

Pay Scale

Anticipated hourly pay range: $45/hr to $54/hr.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws