Senior Pharma CQV Engineer (IQ/OQ/PQ Lead)

Hydrogen Group; Clayton (NC); On-site; USD 130,000 - 150,000; Full time

Job summary

Hydrogen Group seeks an experienced CQV Engineer to support commissioning, qualification, and validation across pharmaceutical manufacturing projects in Clayton, NC. The role leads validation efforts from requirements through decommissioning, with projects spanning facility systems, aseptic filling, packaging, and QC operations.

Candidates must have pharma validation experience and the ability to independently develop and execute validation deliverables after onboarding.

Qualifications

• Demonstrated experience generating and executing validation documentation within a pharmaceutical or regulated GMP manufacturing environment.
• Hands-on experience with commissioning, qualification, and validation activities.
• Strong knowledge of IQ/OQ/PQ, risk assessments, traceability, deviations, and change control.
• Understanding of GMP, FDA, EU Annex 15, and GAMP 5 requirements.
• Ability to independently manage validation deliverables across multiple projects after onboarding.

Responsibilities

• Lead commissioning, qualification, and validation activities for assigned pharmaceutical manufacturing projects.
• Develop, revise, and maintain validation plans, reports, specifications, risk assessments, traceability matrices, and decommissioning documentation.
• Author and execute DQ/IQ/OQ/PQ/Process Validation protocols and reports.
• Support commissioning and qualification activities to ensure equipment and systems are ready for validation execution.
• Participate in FAT where required.
• Track validation documentation, milestones, risks, and deliverables across multiple projects.
• Provide regular project status updates and escalations to Project Managers.
• Identify, investigate, and document deviations and engineering changes encountered during validation.
• Initiate, author, and support Change Controls and assess validation impact of proposed changes.

Skills

Pharma validation experience

IQ/OQ/PQ

GMP FDA knowledge

Documentation skills

On-site Clayton NC

Tools

TIMS/HP ALM

Veeva Vault

QualityDocs

Job description

Hydrogen Group seeks an experienced CQV Engineer to support commissioning, qualification, and validation across pharmaceutical manufacturing projects in Clayton, NC. The role leads validation efforts from requirements through decommissioning, with projects spanning facility systems, aseptic filling, packaging, and QC operations.

Candidates must have pharma validation experience and the ability to independently develop and execute validation deliverables after onboarding.