Senior Validation Manager

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

We are seeking a Senior Validation Manager to lead the Validation Engineering team supporting major capital expansion projects at an established pharmaceutical manufacturing campus. This role will provide technical and people leadership for Commissioning, Qualification, and Validation (CQV) activities as new manufacturing buildings, utilities, equipment, and systems are brought online. The Senior Validation Manager will work closely with the Validation Manager, Engineering, Operations, Quality, project teams, and external partners to drive successful CQV execution from design through startup.

Job Requirements

• Lead CQV strategy and execution for new-build and large-scale pharmaceutical capital projects.
• Manage a team of Senior and Junior Validation Engineers supporting multiple project workstreams.
• Oversee qualification and validation of manufacturing equipment, clean utilities, sterilization/depyrogenation systems, filling, inspection, packaging, labeling, and related systems.
• Provide validation input throughout design, construction, commissioning, qualification, and startup.
• Review and approve validation protocols, reports, strategies, risk assessments, and other lifecycle documentation.
• Develop and maintain CQV schedules while coordinating validation activities with broader capital project timelines.
• Partner with Engineering, Operations, Quality, vendors, and project teams to identify risks, resolve issues, and maintain project momentum.
• Support change management, deviations, regulatory requirements, audits, and inspection readiness.

Job Qualifications

• 10+ years of experience in pharmaceutical validation, CQV, or a related engineering discipline.
• 5+ years of direct people-management experience, preferably leading technical Validation or CQV Engineers.
• Strong experience leading CQV for major pharmaceutical CAPEX, greenfield, or brownfield expansion projects.
• Strong GMP manufacturing experience with demonstrated knowledge of risk-based qualification and validation practices.
• Experience with sterile or aseptic drug product manufacturing strongly preferred.
• Experience with equipment and utility qualification, including clean utilities, sterilization/depyrogenation, filling, inspection, packaging, or labeling systems preferred.
• Bachelor's degree or higher in Engineering, Life Science, or another STEM discipline.