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