Cleaning Validation Engineer III, Manufacturing Science and Technology

Duties and Responsibilities

• Oversees the clinical equipment Cleaning Program with minimal guidance, driving optimizations that facilitate a translation to commercial
• Serves as a subject matter expert on cleaning, providing support around equipment cleaning and verification methods, allowable carryover limit calculations, and release procedures
• Supports Cleaning Program activities, including lifecycle management, CAPAs, and equipment onboarding
• Develops and manages protocols, workplans, and templates within the scope of the Cleaning Program
• Leads cleaning-related projects, assessing impacts of individual changes and collaborating with impacted departments on implementation
• Authors and contributes to technical reports and presentations
• May supervise others and perform job functions within the capacity of a supervisor
• Responsibilities may increase in scope to align with company initiatives
• Performs other related duties as assigned

Required Skills and Abilities

• Strong project management skills with the ability to coordinate multi-departmental projects
• Ability to think strategically and holistically
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Ability to collaborate and work in cross-functional teams
• Ability to function well in a high-paced and at times stressful environment
• Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
• Strong analytical and problem-solving skills
• Ability to prioritize tasks and to delegate them when appropriate
• Willingness to accept feedback from a variety of sources
• Ability to constructively manage conflict

Education and Experience

• B.S. in Science or Engineering discipline with 3+ years of experience; or
• M.S. in Science or Engineering discipline, with 2+ years of experience
• Knowledge of GMP compliance and quality systems; at least two years of GMP experience
• Knowledge of regulatory expectations and industry practices related to cleaning

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 15 pounds at a time regularly and up to 25 pounds occasionally
• Adheres to consistent and predictable in-person attendance
• Motor skills required for basic processing operations (assembling and disassembling equipment, pouring liquids, visual assessments, etc.)