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

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.