Validation - Senior Director, Process & Cleaning Validation
About The Position
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.
Requirements
- Bachelor’s Degree (and/or Masters) in Life Science, Engineering, or related discipline (OR a combination of equivalent experience in CQV engineering, cGMP facility start-up, project management and/or comparable military experience)
- 15+ years advanced therapy, life science, pharmaceutical, or biotech experience
- 10 years minimum managing high-performing teams
- 6 years minimum business development, lead generation, or sales experience
- Travel as needed to fulfill Business Development, client engagement and training initiatives.
- Experience operating as a trusted strategic advisor to organization decision-makers on short and long-term organizational initiatives.
- Experience translating client visions to set the direction, frame the project, provide clarity to direct reports and client, and deliver results
- Proven technical/managerial capabilities in developing solutions to engineering and business problems and managing deliverables and client expectations
- Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position.
- This position may require significant travel to support project and business needs.
- We cannot employ anyone with an invalid driver's license.
Nice To Haves
- Applies advanced technical knowledge and professional expertise
- Seeks better ways, adapts to change and champions new ideas.
- Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
- Demonstrates self-awareness and puts PF mission above ego
- Communicates clearly and proactively and drives transparent alignment with clients.
- Delivers reliably, manages priorities and drives for high quality outcomes
- Shows openness to new ideas, feedback and change
Responsibilities
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
Benefits
- Full-time salaried position
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What This Job Offers
Job Type
Full-time
Career Level
Senior
