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 #J-18808-Ljbffr Harba