Site Process and Cleaning Validation Lead

Team Horizon is seeking a Site Process and Cleaning Validation Lead for a world-class, innovation-driven pharmaceutical manufacturing site. This role offers the opportunity to lead critical validation activities at a high-performing, globally regulated facility, working with advanced technologies and strong quality systems. The successful candidate will provide hands-on technical leadership across process and cleaning validation while influencing cross-functional teams, supporting audits, and driving continuous improvement in a patient-focused environment.

• 
  
• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
  

• 
  
• Develop and implement site-wide master plans for process and cleaning validation activities.
  
• Lead the development, planning, and execution of validation strategies and PPQ protocols, including risk assessments, data evaluation, and technology transfer support.
  
• Oversee the review, approval, and maintenance of validation documentation, reports, and change control records.
  
• Partner cross-functionally with manufacturing, engineering, and quality teams to support continuous improvement initiatives.
  
• Ensure full compliance with global regulatory standards (e.g., FDA, EMA) and internal quality policies.
  
• Manage validation-related investigations, deviations, and the implementation of corrective and preventive actions (CAPAs).
  
• Deliver training to site personnel on validation processes, expectations, and best practices.
  
• Serve as the validation representative during internal audits, external audits, and regulatory inspections.
  
• Participate in risk assessments and design reviews across all business units.
  
• Track, analyze, and report weekly performance metrics (e.g., GTW, QMS, EHS, ComplianceWire).
  
• Support audit readiness activities, actively engage during audits, and contribute to audit responses and follow-up actions, including participation in internal and external audit programs.
  
• Manage revalidation schedules, regulatory response support, laboratory validation document reviews, and APR reporting in collaboration with business unit owners.
  
• Coach, develop, and upskill direct reports to ensure strong technical capability and leadership support at the site level.
  
• Lead, motivate, and communicate effectively with team members and management to drive engagement and performance.
  
• Conduct performance evaluations in line with company policies, including individual development planning.
  
• Maintain appropriate staffing levels aligned with business needs, including recruitment and selection.
  
• Develop and manage departmental budgets to achieve organizational objectives.
  
• Address underperforming KPIs by implementing robust and sustainable preventive action plans.
  

• 
  
• Minimum of 9+ years of experience with a Bachelor’s degree, 7+ years with a Master’s degree, or 5+ years with a PhD in a scientific or engineering discipline (e.g., Chemistry, Microbiology, Pharmacy, Chemical Engineering, or a related field).
  
• At least 7+ years of hands‑on experience in pharmaceutical validation, including process and/or cleaning validation.
  
• Strong working knowledge of validation‑related regulatory requirements and guidelines (cGMP, FDA, EMA, ICH Q7, Q8, Q9, Q10).
  
• Demonstrated strengths in project management, problem‑solving, and organizational skills.
  
• Proven ability to work effectively in cross‑functional teams while managing multiple priorities and projects.
  
• Excellent conflict resolution and stakeholder management skills.
  
• Subject matter expertise in key validation areas such as cleaning validation, CSV, aseptic processing, process validation, and CPV.
  
• Solid understanding of process validation, computer system validation, SCADA systems, continued process verification (CPV), sterilization, packaging systems, and associated technologies.
  
• Strong awareness of current data integrity expectations is highly desirable. xcfaprz
  
• Excellent written and verbal communication and presentation skills, with the ability to clearly and concisely present data to team members and senior management when required.