Validation Program Director, GMP Excellence

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Harba Solutions Inc. is seeking a Lead Validation Engineer to direct the Validation Engineering function.

You will oversee qualification, commissioning, and validation programs for manufacturing equipment and facility systems, and provide hands-on guidance across the validation lifecycle. You will partner with Engineering, Operations, Quality, and other teams to support new installations and process improvements, while leading capital projects and ensuring GMP readiness and documentation

Qualifications

• Bachelor’s degree or higher in Engineering, Life Sciences, or STEM.
• 10+ years of professional experience in validation, qualification, commissioning, or related engineering discipline.
• Significant GMP-regulated manufacturing experience, preferably pharmaceutical or biopharmaceutical.
• Demonstrated experience directly managing validation professionals and leading a technical team.
• Hands-on understanding of equipment qualification, process validation, facility/utilities qualification, and validation lifecycle practices.
• Experience with regulated manufacturing systems and validation documentation (risk assessments, protocols, reports, deviations, change controls).
• Experience supporting complex manufacturing projects, facility expansions, equipment installations, or capital initiatives.
• Willingness to work onsite and regularly engage with manufacturing and project teams.

Responsibilities

• Lead and develop the Validation Engineering function with technical direction and people leadership.
• Oversee commissioning, qualification, and validation programs for manufacturing equipment, facility systems, utilities, and supporting processes.
• Provide hands-on guidance through the validation lifecycle including protocol development, execution, deviation resolution, and final documentation approval.
• Establish validation strategies, procedures, templates, and lifecycle documentation for a compliant program.
• Partner with Engineering, Operations, Quality, and cross-functional teams on equipment installations and process improvements.
• Provide validation leadership for capital projects including planning, resources, scheduling, and timelines.
• Evaluate changes to equipment, processes, systems, and facilities for qualification and GMP requirements.
• Identify gaps and drive remediation to maintain validated state of operations.
• Review and approve validation documentation ensuring alignment with GMP expectations and company procedures.
• Provide technical support during customer interactions, audits, regulatory inspections, and inspections readiness.

Skills

Leadership

Validation engineering

GMP knowledge

Process validation

Equipment qualification

Regulatory inspections

Cross-functional collaboration

Project management

Lean Six Sigma

On-site work

Education

Bachelor’s degree in Engineering

MS preferred

Job description

Harba Solutions Inc. is seeking a Lead Validation Engineer to direct the Validation Engineering function.

You will oversee qualification, commissioning, and validation programs for manufacturing equipment and facility systems, and provide hands-on guidance across the validation lifecycle. You will partner with Engineering, Operations, Quality, and other teams to support new installations and process improvements, while leading capital projects and ensuring GMP readiness and documentation