Process Validation Manager

Job Responsibilities:Lead, develop, and oversee a team of process validation engineers, providing direction on both technical execution and professional growthEstablish team objectives, conduct performance reviews, and implement development plans to strengthen individual and group capabilitiesPartner with senior leadership and HR to support hiring, onboarding, and long-term workforce planningOwn resource planning, prioritization, and allocation across multiple validation programs and site initiativesDrive a culture of accountability, continuous improvement, and safety within the teamServe as a primary technical representative during regulatory inspections, customer audits, and external engagementsDefine and advance validation strategies across the product lifecycle, including process qualification and continued verificationEvaluate and implement new technologies, manufacturing platforms, and data-driven solutions to improve efficiency and complianceReview and approve key validation deliverables such as protocols, reports, risk assessments, and lifecycle documentationAct as a senior technical interface for clients and internal stakeholders, supporting complex discussions and business development effortsLead investigations into significant process issues, ensuring thorough root cause analysis and effective CAPA implementationEnsure all activities are conducted in accordance with cGMP requirements and internal quality standardsQualifications:Bachelor’s degree in Engineering, Life Sciences, or related field required; advanced degree preferred6+ years of experience in a Pharma/CDMO GMP-regulated environment3+ years of leadership experience within process validation or technical operationsStrong 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 approachesProven ability to lead teams, manage competing priorities, and drive results in a fast-paced environmentExperience supporting regulatory inspections and interacting with external agencies or clientsStrong analytical, problem-solving, and communication skills