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Cleaning Validation Engineer III, Manufacturing Science and Technology
Seranbio
Bend, USA
Full-time
Entry
Onsite
Discovered 1 weeks ago
Free
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- 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
- 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
- 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
- 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
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