CQV Engineer - Pharmaceutical Manufacturing

Hydrogen Group; Clayton (NC); Sur place; USD 130 000 - 150 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Pharma validation experience

IQ/OQ/PQ

GMP FDA knowledge

Documentation skills

On-site Clayton NC

Outils

TIMS/HP ALM

Veeva Vault

QualityDocs

Description du poste

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.

Desired Skills and Experience

Commissioning & Qualification (CQV), Validation, GMP, Equipment Qualification, IQ/OQ/PQ, Process Validation, FDA Regulations, EU Annex 15, GAMP 5, Veeva Vault, Change Control, Deviation Management, Aseptic Processing, Pharmaceutical Manufacturing