Sr. Manager, Validation Engineer

Kindeva Drug Delivery•Lexington, KY

2d•Onsite

About The Position

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.