What are the responsibilities and job description for the CQV Engineer position at PharmEng Technology?
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:
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.
- Water for Injection (WFI)
- Clean steam
- Compressed air and process gases
- CIP/SIP systems
- Cleanroom HVAC systems
- Chromatography skids
- Tangential Flow Filtration (TFF) units
- Buffer prep and hold tanks
- Centrifuges
- Formulation vessels and associated skids
- 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.
- 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.