On-Site Senior CQV Engineer — GMP Validation Lead

Visium Resources, Inc.; Raleigh (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Visium Resources, Inc. seeks an experienced Senior CQV Engineer to lead commissioning, qualification, and validation activities for pharmaceutical and biotechnology facilities in Raleigh, NC.

The role involves hands-on CQV work across process equipment, utilities, HVAC, cleanrooms, and automation systems, with cross-functional collaboration to ensure regulatory readiness. The ideal candidate has 5–10+ years in CQV/validation within GMP environments, strong knowledge of cGMP, FDA validation, and

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
• 5–10+ years of CQV, validation, or pharmaceutical engineering experience within GMP-regulated environments.
• Strong knowledge of cGMP regulations, FDA validation requirements, ISPE Baseline Guides, and GAMP 5 principles.
• Experience authoring and reviewing validation lifecycle documentation.
• Ability to work independently within fast-paced project environments.

Responsibilities

• Lead and execute CQV activities for pharmaceutical and biotech capital projects.
• Develop and execute commissioning plans, IQ/OQ/PQ protocols, validation test scripts, traceability matrices, and summary reports.
• Support startup and qualification of process equipment, clean utilities, HVAC systems, manufacturing suites, automation and control systems.
• Coordinate field execution activities with engineering, construction, vendors, and operations teams.
• Perform system walkdowns and turnover package reviews; support deviation investigations, CAPAs, and change control activities.
• Ensure validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines.
• Participate in FAT/SAT execution and acceptance activities; support project schedule development and milestone tracking.
• Collaborate with QA and Manufacturing to support inspection readiness and system release.
• Mentor junior CQV engineers and validation specialists as needed.

Skills

CQV experience

Regulatory compliance

Technical writing

Project coordination

Client communication

Education

Bachelor's degree in Engineering/Life Sciences/ Biotechnology

Tools

DeltaV

MES systems

SCADA platforms

Kneat

Job description

Visium Resources, Inc. seeks an experienced Senior CQV Engineer to lead commissioning, qualification, and validation activities for pharmaceutical and biotechnology facilities in Raleigh, NC.

The role involves hands-on CQV work across process equipment, utilities, HVAC, cleanrooms, and automation systems, with cross-functional collaboration to ensure regulatory readiness. The ideal candidate has 5–10+ years in CQV/validation within GMP environments, strong knowledge of cGMP, FDA validation, and