Senior CQV Engineering Lead for Pharma Capital Projects

Harba Solutions Inc.; Indiana (PA); On-site; USD 130,000 - 190,000; Full time

Job summary

Harba Solutions Inc. seeks a Senior Validation Manager to lead the Validation Engineering team on major pharmaceutical capital expansion projects.

You will drive CQV execution from design through startup, coordinating with Engineering, Operations, Quality, and external partners to ensure compliant, on-time validation deliverables. The role requires extensive CQV/DQ/IQ/OQ/PQ experience, strong GMP knowledge, and proven leadership across large-scale projects.

Qualifications

• 10+ years of pharmaceutical validation/CQV experience.
• 5+ years of direct people-management experience.
• Proven track record leading CQV for large CAPEX projects.
• GMP manufacturing experience with risk-based qualification.
• Experience with sterile or aseptic drug manufacturing preferred.
• Bachelor's degree or higher in Engineering, Life Science, or STEM.

Responsibilities

• Lead CQV strategy and execution for new-build/large-scale projects.
• Manage a team of Senior and Junior Validation Engineers.
• Oversee qualification and validation of manufacturing equipment and utilities.
• Provide validation input throughout design, construction, commissioning, startup.
• Review and approve validation protocols, reports, and risk assessments.
• Develop and maintain CQV schedules; coordinate with capital project timelines.
• Collaborate with Engineering, Operations, Quality, vendors and project teams.

Skills

CQV leadership

People management

GMP knowledge

Risk-based qualification

Sterile/aseptic manufacturing

Education

Bachelor's degree in Engineering/Life Science

Job description

Harba Solutions Inc. seeks a Senior Validation Manager to lead the Validation Engineering team on major pharmaceutical capital expansion projects.

You will drive CQV execution from design through startup, coordinating with Engineering, Operations, Quality, and external partners to ensure compliant, on-time validation deliverables. The role requires extensive CQV/DQ/IQ/OQ/PQ experience, strong GMP knowledge, and proven leadership across large-scale projects.