CQV Engineer - Pharma Manufacturing (On-Site, Clayton)

Hydrogen Group; Georgia; On-site; USD 158,314,000 - 214,189,000; Full time

Job summary

Hydrogen Group seeks an experienced CQV Engineer to drive commissioning, qualification, and validation across pharmaceutical manufacturing projects in Clayton, NC. You will develop and execute IQ/OQ/PQ protocols, ensure readiness of equipment, and manage validation deliverables across concurrent projects.

The role requires GMP/regulated environment experience, strong technical documentation, and the ability to work on-site in Clayton, NC with occasional after-hours work during major validations.

Qualifications

• Demonstrated experience validating pharma processes in GMP environments.
• Hands-on validation activities across IQ/OQ/PQ.
• Knowledge of GMP, FDA, EU Annex 15, GAMP 5.
• Ability to manage multiple projects after onboarding.
• On-site in Clayton, NC.
• Willingness for after-hours as needed.

Responsibilities

• Lead commissioning, qualification, and validation activities for assigned pharmaceutical manufacturing projects.
• Develop, revise, and maintain validation plans, reports, specs, risk assessments, traceability matrices, and decommissioning documentation.
• Author and execute IQ/OQ/PQ, FAT, and process validation protocols and reports.
• Support validation readiness of equipment and systems for execution.
• Track validation milestones, risks, and deliverables across projects.
• Provide updates and escalations to Project Managers.
• Identify deviations and engineering changes and document them.
• Initiate and support Change Controls and assess validation impact.

Skills

IQ/OQ/PQ

Risk assessments

Traceability

Deviations

Change control

Technical documentation

Project coordination

On-site work

Tools

TIMS

HP ALM

Veeva QualityDocs

Vault Quality

SCADA

PLC

PAS-X

LMES

Job description

Hydrogen Group seeks an experienced CQV Engineer to drive commissioning, qualification, and validation across pharmaceutical manufacturing projects in Clayton, NC. You will develop and execute IQ/OQ/PQ protocols, ensure readiness of equipment, and manage validation deliverables across concurrent projects.

The role requires GMP/regulated environment experience, strong technical documentation, and the ability to work on-site in Clayton, NC with occasional after-hours work during major validations.