More jobs:
CQV Engineer
Job in
Raleigh, Wake County, North Carolina, 27601, USA
Listed on 2026-01-01
Listing for:
PharmEng Nordic ApS
Full Time
position Listed on 2026-01-01
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering
Job Description & How to Apply Below
Job Title: C&Q Engineer (Mid
-Senior Level) Clean Utilities & Downstream Equipment
Location: Toronto,ON, CA & Raleigh, NC, USA
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. This position is part of a project team that delivers 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 and be familiar 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, punch‑list 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 escape deviations and support resolution and closeout.
Clean Utilities:
- 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
- Formulation vessels and associated skids
- Bachelor's 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 Delta
V, SCADA, or building management/automation systems. - Experience using commissioning tracking tools or turnover documentation systems.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×