Cleaning Validation Lead: GMP for Clinical to Commercial

Serán BioScience; Bend (OR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Generous PTO accrual

Low-cost health benefits

5% 401(k) contribution (no match/vest)

Job summary

Serán BioScience in Bend, Oregon is seeking a Cleaning Validation Engineer III to oversee the equipment Cleaning Program, ensure GMP-compliant cleanliness, and support clinical manufacturing while positioning the program for future commercial operations. You will collaborate across functions on optimization, develop and manage protocols, lead projects, and prepare technical reports.

The role may involve supervision and expanding scope as the company evolves, with emphasis on quality systems and

Qualifications

• B.S. or M.S. in science or engineering with required years of experience.
• GMP knowledge and quality systems experience are required.
• Two+ years GMP experience preferred.

Responsibilities

• Oversee clinical equipment Cleaning Program with minimal guidance and drive optimizations for translation to commercial.
• Serve as SME on cleaning, providing support around equipment cleaning and verification methods, carryover limit calculations, and release procedures.
• Support Cleaning Program activities, lifecycle management, CAPAs, and equipment onboarding.
• Develop and manage protocols, workplans, and templates within the Cleaning Program.
• Lead cleaning-related projects and collaborate with impacted departments on implementation.
• Author and contribute to technical reports and presentations.
• May supervise others and adapt responsibilities as the company evolves.

Skills

Project management

Strategic thinking

Communication

Organizational skills

Time management

Cross-functional collaboration

High-paced environment

Relationship building

Analytical and problem solving

Prioritization / delegation

Feedback handling

Conflict management

Education

B.S. in Science or Engineering

M.S. in Science or Engineering

Job description

Serán BioScience in Bend, Oregon is seeking a Cleaning Validation Engineer III to oversee the equipment Cleaning Program, ensure GMP-compliant cleanliness, and support clinical manufacturing while positioning the program for future commercial operations. You will collaborate across functions on optimization, develop and manage protocols, lead projects, and prepare technical reports.

The role may involve supervision and expanding scope as the company evolves, with emphasis on quality systems and