Validation Manager

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 140,000 - 200,000; Full time

Job summary

Harba Solutions Inc. in Indianapolis is seeking a senior leader to head the Validation Engineering function.

You will provide technical direction and people leadership across qualification and validation activities, and oversee commissioning, qualification, and validation programs for manufacturing equipment, facility systems, utilities, and supporting processes. You will partner with Engineering, Operations, Quality, and other teams to support new installations, upgrades, and process

Qualifications

• Bachelor’s degree or higher in Engineering, Life Sciences, or another relevant STEM discipline.
• 10+ years of professional experience in validation, qualification, commissioning, or a closely related engineering discipline.
• Significant GMP-regulated manufacturing experience, preferably pharmaceutical or biopharmaceutical manufacturing.
• Demonstrated experience directly managing validation professionals and leading a technical team.
• Strong hands-on understanding of equipment qualification, process validation, facility/utilities qualification, and validation lifecycle practices.
• Experience working with regulated manufacturing systems and validation documentation, including risk assessments, protocols, reports, deviations, and change controls.
• Experience supporting complex manufacturing projects, facility expansions, equipment installations, or other capital initiatives.
• Working knowledge of FDA/GMP expectations and risk-based validation principles.
• Experience with sterile, aseptic, injectable, or other highly regulated manufacturing environments is strongly preferred.
• Exposure to cleaning validation, sterilization/depyrogenation, filling, inspection, packaging, or automated manufacturing systems is a plus.

Responsibilities

• Lead and develop the Validation Engineering function, providing technical direction and people leadership across qualification and validation activities.
• Oversee commissioning, qualification, and validation programs for manufacturing equipment, facility systems, utilities, and supporting processes.
• Provide hands-on technical guidance throughout the validation lifecycle, including protocol development, execution, deviation resolution, and final documentation approval.
• Establish and maintain validation strategies, procedures, templates, and lifecycle documentation to support a compliant and consistent validation program.
• Partner with Engineering, Operations, Quality, and other cross-functional teams to support new equipment installations, facility upgrades, process improvements, and ongoing manufacturing activities.
• Provide validation leadership for capital projects, including planning, resource coordination, scheduling, execution, and maintaining project timelines.
• Evaluate changes to equipment, processes, systems, and facilities to determine appropriate qualification, validation, risk assessment, and GMP requirements.
• Support the continued validated state of manufacturing operations by identifying gaps, driving remediation efforts, and ensuring validation programs remain current.
• Review and approve validation documentation while ensuring activities are aligned with applicable GMP expectations, company procedures, and industry standards.
• Provide technical support during customer interactions, audits, regulatory inspections, product introductions, and other external-facing activities.
• Work closely with Quality and regulatory teams on validation-related submissions, inspection readiness, and responses to technical questions.
• Identify opportunities to improve validation processes, reduce inefficiencies, and introduce risk-based and continuous improvement practices.
• Build and maintain a strong validation organization through coaching, performance management, technical development, and effective resource planning.

Skills

Leadership

Validation

GMP

Protocol development

Deviation resolution

Risk assessment

Project management

Regulatory submissions

Stakeholder communication

Onsite collaboration

Education

Bachelor's degree

Job description

• Lead and develop the Validation Engineering function, providing technical direction and people leadership across qualification and validation activities.
• Oversee commissioning, qualification, and validation programs for manufacturing equipment, facility systems, utilities, and supporting processes.
• Provide hands‑on technical guidance throughout the validation lifecycle, including protocol development, execution, deviation resolution, and final documentation approval.
• Establish and maintain validation strategies, procedures, templates, and lifecycle documentation to support a compliant and consistent validation program.
• Partner with Engineering, Operations, Quality, and other cross‑functional teams to support new equipment installations, facility upgrades, process improvements, and ongoing manufacturing activities.
• Provide validation leadership for capital projects, including planning, resource coordination, scheduling, execution, and maintaining project timelines.
• Evaluate changes to equipment, processes, systems, and facilities to determine appropriate qualification, validation, risk assessment, and GMP requirements.
• Support the continued validated state of manufacturing operations by identifying gaps, driving remediation efforts, and ensuring validation programs remain current.
• Review and approve validation documentation while ensuring activities are aligned with applicable GMP expectations, company procedures, and industry standards.
• Provide technical support during customer interactions, audits, regulatory inspections, product introductions, and other external‑facing activities.
• Work closely with Quality and regulatory teams on validation‑related submissions, inspection readiness, and responses to technical questions.
• Identify opportunities to improve validation processes, reduce inefficiencies, and introduce risk‑based and continuous improvement practices.
• Build and maintain a strong validation organization through coaching, performance management, technical development, and effective resource planning.

Qualifications:

• Bachelor’s degree or higher in Engineering, Life Sciences, or another relevant STEM discipline.
• 10+ years of professional experience in validation, qualification, commissioning, or a closely related engineering discipline.
• Significant experience working within a GMP‑regulated manufacturing environment, preferably pharmaceutical or biopharmaceutical manufacturing.
• Demonstrated experience directly managing validation professionals and leading a technical team.
• Strong hands‑on understanding of equipment qualification, process validation, facility/utilities qualification, and validation lifecycle practices.
• Experience working with regulated manufacturing systems and validation documentation, including risk assessments, protocols, reports, deviations, and change controls.
• Experience supporting complex manufacturing projects, facility expansions, equipment installations, or other capital initiatives.
• Working knowledge of FDA/GMP expectations and risk‑based validation principles.
• Experience with sterile, aseptic, injectable, or other highly regulated manufacturing environments is strongly preferred.
• Exposure to cleaning validation, sterilization/depyrogenation, filling, inspection, packaging, or automated manufacturing systems is a plus.
• Strong communication and interpersonal skills, with the ability to influence decisions across Engineering, Operations, Quality, and other functions.
• Ability to balance strategic leadership responsibilities with hands‑on technical problem solving in a fast‑paced manufacturing environment.
• Lean Six Sigma, continuous improvement, or similar process improvement experience is a plus.
• Ability to work onsite and regularly engage with manufacturing and project teams.