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Senior Commissioning & Qualification (C&Q) Engineer
RCM Technologies, Inc. | Life Sciences / Data & Solutions
- 🇺🇸 United States
- Hybrid
- Senior
- 1 week ago
- HVAC
- GMP
- Airflow
- calibration
- Windows
- CAPA
- ASTM
- VFDs
- Veeva Vault
- SCADA
1 week ago
Contract
Title:Â Senior Commissioning & Qualification (C&Q) Engineer: HVAC / Cleanroom Systems
Compensation: Up to $70/hr., commensurate with exp.
Location:Â Onsite, Durham, NCÂ
Length of Contract 2 months +
Position Summary
RCM is seeking a Senior C&Q Engineer to lead the investigation, correction, and qualification of a redundant rooftop air handling unit (AHU) that supports six production AHUs serving Grade C and Grade D classified space. During an automatic failover event, only three of the unit's four supply fans ran. You will find out why, support the fix, document the failover sequence, and qualify the unit for GMP use.
You will be RCM's dedicated on-site lead, working directly with the client's System Engineer, Quality Assurance, Facilities, and vendors with executive oversight from RCM leadership.
Responsibilities
- Root cause investigation: Lead the investigation of the fan failure across fan and VFD hardware, power and wiring, fan status proofing, and Metasys start and fan-staging logic. Pull and analyze Metasys alarm and trend history and PI Historian data (fan commands and status, VFD speed and faults, damper positions, airflow, room differential pressure).
- Corrective action and verification: Define the corrective change request and test plan; witness repairs and program changes performed by the client, JCI, or Daikin, and verify them with post-change functional checks.
- Drawings and documentation: Field-verify and redline AHU-M mechanical, ATC, and electrical drawings; document the sequence of operations, point list, and alarm set points, including automatic failover.
- IOV protocol: Revise and execute IOV protocol D-125853 (v2.0), adding automatic failover test cases for each of six production AHUs alongside maintenance-mode tests.
- IOV execution: Execute installation and operational verification (drawing walkdowns, wiring and VFD checks, instrument calibration, alarm and interlock tests, loss-of-fan and VFD fault tests, failover simulations) in approved production windows with live differential pressure trending, defined abort criteria, and immediate return of production AHUs if needed.
- Non-conformances and procedures: Manage non-conformances per site procedures and support deviation and CAPA close-out; draft AHU-M sections of the AHU operating procedure (D-11507) and build the requirements traceability matrix to the URS.
- Reports, turnover, and performance verification: Compile the IOV summary report and engineering turnover package; complete return-to-service documentation. Coordinate performance verification in Grade C/D areas (DP, temperature, RH trending; at-rest particle counts with QC) and oversee certified TAB subcontractors where applicable.
- Follow-on phase and reporting: Perform quarterly simulated failover tests, monthly trend reviews, BMRAM PM/calibration records, and change-control impact assessments. Provide weekly status reports (progress, risks, open non-conformances, hours) and escalate issues early.
- 7+ years of commissioning and qualification experience in GMP-regulated manufacturing (biopharma, cell/gene therapy, or sterile products)
- Hands-on experience qualifying HVAC/AHU systems serving classified cleanrooms, including pressure cascades and differential pressure control
- Strong working knowledge of building automation systems, ideally Johnson Controls Metasys: logic review, trends, alarms, point mapping
- Experience writing and executing IQ/OQ or IOV protocols, managing deviations and non-conformances, and producing summary reports and turnover packages
- Working knowledge of ISPE Baseline Guide Vol. 5, ASTM E2500, EU GMP Annex 1, and ISO 14644
- Practical troubleshooting skills with VFDs, motors, dampers, and fan arrays
- Excellent documentation (GDP), communication, and stakeholder management skills; comfortable leading discussions with QA, Facilities, and vendors
- Prior experience investigating redundant or backup AHU failover or staging issues
- Familiarity with Veeva Vault, BMRAM, PI Historian, and plant SCADA
- Experience with CSV review of control system program changes
- TAB Certified and Familiarity with TAB reports (NEBB/AABC) and interpreting results
- Professional credentials (PE, CQE, CCP, or similar) a plus
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Equal Opportunity Employer:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
About RCM:
RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Senior Commissioning & Qualification (C&Q) Engineer · RCM Technologies, Inc. | Life Sciences / Data & Solutions