Validation - Senior Director, Process & Cleaning Validation

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Validation - Senior Director, Process & Cleaning Validation

Location(s)

Customer Site - IN

Job Description

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will be willing to travel domestically and internationally, to meet client project requests.

Project Farma's purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

All team members are expected to embody Project Farma's values by being curious , personable , and unselfish , while maintaining a strong commitment to a Patient Focused and People First mindset .

The Senior Director, Process & Cleaning Validation Services is a senior leader responsible for setting direction, driving execution, and delivering results across the Validation Services Practice Area, with a technical focus on process validation, cleaning and sterilization validation, and holistic validation lifecycle programs. This role provides strategic leadership, oversees multiple project teams or initiatives, and partners cross-functionally to align people, processes, and priorities with the company objectives. This role carries enterprise-level accountability for strategic direction, leadership development, and sustained business performance across a significant organizational scope. The incumbent shapes and influences decisions at scale, ensures operational excellence, and builds leadership capability - balancing near-term execution priorities with long-term growth objectives.

Key Responsibilities

Practice Leadership & Standardization

• Define and maintain standardized approaches, templates, and SOPs for process validation and cleaning and sterilization validation across the organization
• Ensure alignment with current regulatory frameworks including FDA Process Validation Guidance, ICH Q7/Q8/Q9, Annex 1, and other relevant guidance
• Champion holistic validation lifecycle approaches, integrating process design, qualification, and continued process verification (CPV) stages
• Serve as the internal authority on process and cleaning validation strategy, methodology, and regulatory expectations
• Monitor industry trends, guidance updates, and emerging science to keep the practice current and competitive . Share this knowledge and insight with clients and the greater industry as an ongoing business practice.

Training & Knowledge Development

• Develop and maintain a current comprehensive training curriculum covering process validation lifecycle stages, cleaning validation principles, and applicable regulatory standards
• Drive consistent technical competency across staff through onboarding programs, ongoing training, and formal assessments
• Create and manage a library of training resources, case studies, and reference materials to support continuous learning related to process, cleaning and sterilization validation principles.
• Identify knowledge gaps and proactively design content to address evolving regulatory and industry requirements

Innovation & Lifecycle Modernization

• Lead adoption of modern lifecycle-based validation approaches integrating continued process verification (CPV) and statistical process control (SPC)
• Respond to growing industry demand for holistic validation lifecycle programs as pharma companies embrace more integrated approaches to process and cleaning validation
• Develop risk-based frameworks that align validation rigor with product and process criticality
• Evaluate and implement emerging technologies and data analytics tools to enhance validation program effectiveness and efficiency

Business Growth & Development

• Support growth of the Process & Cleaning Validation service line by identifying and pursuing new client opportunities
• Contribute to proposals, scope development, and client presentations to expand the practice revenue base
• Build and maintain strong client relationships, acting as a trusted technical advisor on validation strategy and regulatory compliance
• Collaborate with business development and other practic