CQV Engineer – Pharmaceutical Manufacturing

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

CQV Engineer - Pharmaceutical Manufacturing

Location: Clayton, North Carolina
Contract: 24 months, with potential for extension
Pay Rate: $65/hour
Work Model: On-site

We are seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities across pharmaceutical manufacturing projects in Clayton, NC.

The CQV Engineer will lead validation efforts for assigned projects from requirements definition through qualification, validation, change control, and decommissioning. Projects may involve facility systems, aseptic formulation and filling, medical device assembly, packaging, warehouse and QC operations, manufacturing systems, and computerized equipment.

This position requires previous pharmaceutical validation experience and the ability to independently develop and execute validation deliverables following an initial onboarding period.

Key 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 Design Qualification/Review, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation protocols and reports.

• Support commissioning and qualification activities to ensure equipment and systems are ready for validation execution.

• Participate in Factory Acceptance Testing (FAT) where required.

• Track validation documentation, milestones, risks, and deliverables across multiple concurrent 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 the validation impact of proposed changes.

• Participate in recurring project meetings and lead focused validation meetings when required.

• Use electronic validation and quality systems such as TIMS/HP ALM and Veeva QualityDocs/Vault Quality.

• Ensure validation activities comply with GMP, FDA requirements, EU Annex 15, GAMP 5, and applicable company procedures.

• Support project activities during plant shutdowns, which may occasionally require evening or weekend work.

Preferred Experience

Candidates with pharmaceutical validation experience in one or more of the following areas are particularly relevant:

• Manufacturing equipment upgrades and production line modifications

• Aseptic formulation and filling equipment, including RABS

• Vision inspection systems

• Medical device assembly equipment

• Pharmaceutical packaging equipment

• Process control and manufacturing execution systems, including SCADA, PLC, PAS-X, and LMES

• Laboratory and GMP facility modifications

• Process instrumentation, monitoring, and calibration systems

• BMS, HVAC, refrigeration, and facility utility systems

• Electrical distribution, switchgear, and controls

• Physical security, access control, and CCTV systems

• Technology modernization and lifecycle replacement projects

• Electronic validation documentation and execution

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 applicable GMP, FDA, EU Annex 15, and GAMP 5 requirements.

• Ability to independently manage validation deliverables across multiple projects after onboarding.

• Strong technical documentation, communication, and project coordination skills.

• Ability to work on‑site in Clayton, North Carolina.

• Flexibility to support occasional evening or weekend activities during major project execution or plant shutdowns.

This is an excellent opportunity for an experienced CQV or Validation Engineer to join a long‑term pharmaceutical manufacturing program and work across a diverse portfolio of equipment, facility, automation, and manufacturing projects.

…