Computer System Validation Manager Jobs in Kentucky

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.

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