Validation - Senior Director, Process & Cleaning Validation

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.

About the Role

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. 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 company objectives. The role carries enterprise-level accountability for strategic direction, leadership development, and sustained business performance across a significant organizational scope.

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 with clients and the industry
• 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
  • 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
  • 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 CRM system
  • Speak at 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 Farma standards, and applicable regulatory expectations
  • Serve as subject matter expert and escalation point for complex technical challenges across active projects
  • Maintain direct engagement on key accounts to ensure technical quality and client satisfaction
• Operational Performance & Billability
  • Maintain a level of individual billability through direct client delivery while concurrently leading practice-level responsibilities
  • Track and report on practice-level metrics including project performance, utilization, and delivery quality
  • Support resource planning and allocation decisions to optimize team productivity and client service
  • Identify and escalate operational risks that may impact project timelines, scope, or quality

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professional expertise
• Innovation & Continuous Improvement: Seeks better ways, adapts to change, and champions new ideas
• Customer Focus & Professionalism: Represents Project Farma with consistent professionalism and respect for stakeholders
• Integrity & Humility: Demonstrates self-awareness and puts the mission above ego
• Collaboration & Communication: Communicates clearly and proactively, driving transparent alignment with clients
• Project Execution: Delivers reliably, manages priorities, and drives for high-quality outcomes
• Growth Mindset: Shows openness to new ideas, feedback, and change

Requirements

• Bachelor’s Degree (and/or Master’s) in Life Science, Engineering, or related discipline (or equivalent experience in CQV engineering, cGMP facility start-up, project management, or comparable military experience)
• 15+ years of advanced therapy, life science, pharmaceutical, or biotech experience
• 10+ years managing high-performing teams
• 6+ years of business development, lead generation, or sales experience
• Experience operating as a trusted strategic advisor to organizational decision-makers on short- and long-term initiatives
• Experience translating client visions to set direction, frame projects, and deliver results
• Proven technical/managerial capabilities in developing solutions to engineering and business problems and managing deliverables and client expectations
• Travel as needed for business development, client engagement, and training initiatives
• Must be authorized to work in the United States on a full-time basis; no visa sponsorship available for this position
• Valid driver’s license required

Pay

The annual compensation range for this full-time position is $177,000 - $195,000. The final base pay offered will be determined by factors including internal equity, work location, and individual qualifications such as job-related skills, experience, and relevant education or training.