Senior Process Validation Manager

Job Responsibilities:

• Lead, develop, and oversee a team of process validation engineers, providing direction on both technical execution and professional growth
• Establish team objectives, conduct performance reviews, and implement development plans to strengthen individual and group capabilities
• Partner with senior leadership and HR to support hiring, onboarding, and long-term workforce planning
• Own resource planning, prioritization, and allocation across multiple validation programs and site initiatives
• Drive a culture of accountability, continuous improvement, and safety within the team
• Serve as a primary technical representative during regulatory inspections, customer audits, and external engagements
• Define and advance validation strategies across the product lifecycle, including process qualification and continued verification
• Evaluate and implement new technologies, manufacturing platforms, and data-driven solutions to improve efficiency and compliance
• Review and approve key validation deliverables such as protocols, reports, risk assessments, and lifecycle documentation
• Act as a senior technical interface for clients and internal stakeholders, supporting complex discussions and business development efforts
• Lead investigations into significant process issues, ensuring thorough root cause analysis and effective CAPA implementation
• Ensure all activities are conducted in accordance with cGMP requirements and internal quality standards

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field required; advanced degree preferred
• 6+ years of experience in a Pharma/CDMO GMP-regulated environment
• 3+ years of leadership experience within process validation or technical operations
• Strong background in process validation for pharmaceutical or combination product manufacturing (e.g., formulation, aseptic processing, device assembly)
• Deep understanding of validation lifecycle concepts, regulatory expectations (CMC), and risk management approaches
• Proven ability to lead teams, manage competing priorities, and drive results in a fast-paced environment
• Experience supporting regulatory inspections and interacting with external agencies or clients
• Strong analytical, problem-solving, and communication skills