Sr. Manager, Validation Engineer

Our Work Matters At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make As a Senior Validation Manager, you will provide strategic and technical leadership for validation activities supporting manufacturing processes, equipment, utilities, and computerized systems within a regulated pharmaceutical CDMO environment. You will lead a team of Validation Engineers and ensure validation activities are executed using a risk-based, science-driven approach that supports operational readiness, inspection readiness, customer expectations, and business objectives.   Responsibilities Validation Leadership & Strategy • Provide leadership, direction, and technical guidance to Validation Engineers, ensuring consistent application of risk-based validation principles across all validation activities. • Establish validation priorities, allocate resources, and drive execution to meet site, project, customer, and regulatory timelines. • Lead continuous improvement initiatives focused on validation lifecycle execution, documentation efficiency, risk management, and operational excellence. • Support and lead process improvement initiatives, including Lean and Six Sigma methodologies.   Validation Execution, Compliance & Technical Oversight • Ensure validation activities comply with FDA, EMA, ICH, cGMP, and other applicable regulatory requirements and industry standards. • Provide technical oversight for equipment, process, utility, and computerized system validation activities. • Review and approve validation protocols, technical reports, investigations, and supporting documentation to ensure compliance, accuracy, and audit readiness. • Serve as a subject matter expert for validation strategy and risk-based decision making during internal audits, customer audits, and regulatory inspections. • Participate in inspection readiness activities and support regulatory agency interactions as required.   Cross-Functional & Customer Engagement • Serve as a technical liaison between Validation, Quality, Manufacturing, Engineering, Regulatory Affairs, Project Management, and external customers. • Support New Product Introduction (NPI) activities by developing and executing validation strategies that align with project objectives and customer requirements. • Partner with internal and external stakeholders to ensure validation deliverables support business priorities, operational readiness, and successful project execution. People Leadership & Quality Systems • Lead, coach, mentor, and develop Validation Engineers through performance management, career development, and technical training. • Establish clear expectations, objectives, and accountability measures for team members while fostering a culture of collaboration and continuous improvement. • Review and approve SOPs, validation protocols, technical reports, deviations, CAPAs, change controls/MOCs, and other GMP documentation. • Ensure validation documentation remains inspection-ready and that validation-related commitments, actions, and audit observations are closed in a timely manner.   Qualifications • Bachelor's degree in Engineering, Life Sciences, or a related scientific discipline; equivalent experience may be considered. • Minimum of 10 years of validation experience within the pharmaceutical, biotechnology, medical device, or related regulated industry. • Minimum of 3 years of supervisory experience or demonstrated experience leading validation teams. • Strong knowledge of cGMP regulations, validation lifecycle principles, and global regulatory requirements including FDA, EMA, and ICH guidelines. • Experience with equipment, process, utility, and computerized system validation (CSV). • Demonstrated expertise in risk-based validation approaches, investigations, CAPAs, change management, and quality systems. • Strong communication skills with the ability to effectively engage customers, regulatory agencies, and cross-functional teams. • Proven leadership, organizational, project management, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.   Preferred Qualifications • Experience working within a CDMO environment supporting multiple customers and concurrent projects. • Six Sigma Green Belt certification or equivalent continuous improvement experience. • Experience supporting customer audits, regulatory inspections, and validation strategy discussions with external stakeholders.   Physical Requirements • Must wear all required personal protective equipment and perform assigned work safely. • Must follow all cGMP and site safety requirements. • Must use proper lifting techniques and remain aware of workplace hazards. • Must occasionally lift and/or move up to 20 pounds. • Ability to work within manufacturing, laboratory, warehouse, and office environments as required. #LI-Onsite #WH