CQV Engineer
Listed on 2026-02-28
-
Engineering
Quality Engineering, Validation Engineer, Pharma Engineer, Process Engineer
Job Title: C&Q Engineer (Mid
-Senior Level) Clean Utilities & Downstream Equipment
Location: Greater Raleigh Area, NC
Industry: Pharmaceutical Manufacturing
Employment Type: Full-Time or Contract
We are looking for a mid- to senior-level Commissioning & Qualification (C&Q) Engineer to support project execution at a pharmaceutical manufacturing facility in the Greater Raleigh area
. This position is part of a project team focused on delivering commissioning and qualification activities for clean utility systems and downstream process equipment
.
This is a field-based, execution-oriented role. The ideal candidate will have hands‑on experience with GMP systems, familiarity with clean utilities and downstream process equipment.
Key Responsibilities:Support the preparation and execution of commissioning and qualification (IQ/OQ) protocols for clean utilities and downstream equipment.
Perform P&, loop checks, component verifications, and functional testing.
Participate in FAT/SAT, equipment installation verification, punchlist tracking, and issue resolution.
Assist with generating turnover packages (TOPs), traceability matrices, and related documentation.
Collaborate with QA, automation, and construction teams to ensure systems are delivered per GMP and project standards.
Document and escalates deviations and support resolution and closeout.
Systems in Scope:Clean Utilities:
Clean steam
Compressed air and process gases
CIP/SIP systems
Cleanroom HVAC systems
Downstream Equipment:
Chromatography skids
Tangential Flow Filtration (TFF) units
Buffer prep and hold tanks
Formulation vessels and associated skids
Qualifications:Bachelors degree in Engineering, Life Sciences, or related technical field.
5+ years of experience in C&Q within pharmaceutical or biotech GMP facilities.
Proven experience with clean utility systems and downstream manufacturing equipment.
Proficiency with Kneat for protocol development, execution, and documentation.
Familiarity with P&IDs, engineering documentation, and protocol execution standards.
Understanding of cGMP, ASTM E2500, and risk-based C&Q practices.
Strong communication, organization, and technical writing skills.
Collaborative mindset and ability to work effectively within cross-functional teams.
Preferred Experience:Project experience in greenfield or facility expansion projects.
Exposure to Delta
V, SCADA, or building management/automation systems.
Experience using commissioning tracking tools or turnover documentation systems.
Join our team and play a critical role in supporting the startup and qualification of essential GMP systems for a leading pharmaceutical client in the Greater Raleigh area
. Opportunities are available for both full-time and contract roles.
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