Validation Manager

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.

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.