Sr. Manager, Validation Engineer

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeAs 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 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 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 -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 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 Bachelors 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 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 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