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Validation - Senior Director, Process & Cleaning Validation
Newperkinelmer
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About this role
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 practice leaders to identify cross-sell opportunities across service lines • Maintain business development activity and pipeline data within the firm's customer relationship management (CRM) system • Speak at multiple industry events and publish insights in reputable publications
Leadership & Talent Development • Provide technical mentorship and career development guidance to consultant staff within the P&CV practice • Support talent acquisition by identifying staffing needs, participating in interviews, and onboarding new team members • Foster a culture of technical excellence, accountability, and continuous improvement within the team • Contribute to performance management processes and provide input on staff development plans
Technical Delivery • Provide technical oversight and quality review on P&CV project deliverables including validation plans, protocols, reports, and risk assessments • Ensure deliverables meet client requirements, Project Far
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