Senior CQV Engineer: Pharma Validation Leader

Visium Resources, Inc.; North Carolina; On-site; USD 120,000 - 170,000; Full time

Job summary

Visium Resources, Inc. in Raleigh, NC is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for pharma and biotech facilities on-site.

You will develop IQ/OQ/PQ protocols, validation scripts, and summary reports while coordinating with engineering, QA, manufacturing, and external vendors. The role requires 5–10+ years of CQV/validation experience in GMP environments, strong knowledge of cGMP, FDA validation, ISPE, and GAMP 5, and the ability to mentor

Qualifications

• Bachelor-level engineering or life sciences degree required with GMP exposure.
• 5–10+ years in CQV/validation within GMP environments.
• Solid knowledge of cGMP, FDA validation, ISPE Baseline Guides, and GAMP 5.
• Experience writing and reviewing validation lifecycle documentation.
• Ability to lead cross-functional teams and document results clearly.

Responsibilities

• Lead CQV activities for pharma/biotech capital projects in a fast-paced setting.
• Develop and execute commissioning plans, IQ/OQ/PQ protocols, and validation scripts.
• Coordinate field execution with engineering, vendors, and operations.
• Ensure validation docs align with cGMP, FDA, ISPE, and GAMP guidelines.
• Mentor junior CQV engineers and contribute to inspection readiness.

Skills

CQV

Validation

Technical writing

Project coordination

GMP compliance

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline

Tools

DeltaV

MES

SCADA

Kneat

Job description

Visium Resources, Inc. in Raleigh, NC is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for pharma and biotech facilities on-site.

You will develop IQ/OQ/PQ protocols, validation scripts, and summary reports while coordinating with engineering, QA, manufacturing, and external vendors. The role requires 5–10+ years of CQV/validation experience in GMP environments, strong knowledge of cGMP, FDA validation, ISPE, and GAMP 5, and the ability to mentor