CQV Engineer Position Available In Wake, North Carolina
Tallo's Job Summary: We are hiring a mid- to senior-level C&Q Engineer for clean utilities and downstream equipment in the pharmaceutical manufacturing industry in the Greater Raleigh Area, NC. The role involves commissioning and qualification activities, collaboration with project teams, and ensuring systems meet GMP standards. Ideal candidates have 5+ years of relevant experience and a Bachelor's degree in Engineering or Life Sciences.
Job Description
CQV Engineer
About the job
CQV 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 Position Summary:
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:
Commissioning & Qualification:
Support the preparation and execution of commissioning and qualification (IQ/OQ) protocols for clean utilities and downstream equipment. Perform P&ID walkdowns, 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 escalate deviations and support resolution and closeout. Systems in
Scope:
Clean Utilities:
Water for Injection (WFI) 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 Centrifuges 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 c
GMP, 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 DeltaV, 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.
