Senior Cleaning Validation Engineer – GMP Compliance

Ring Inc; Bend (OR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

PTO accrual

Health benefits

5% 401(k) contribution

Job summary

Serán BioScience seeks a Cleaning Validation Engineer III to drive the clinical equipment Cleaning Program and shape its path toward commercial manufacturing. The role partners with cross-functional teams to optimize cleaning methods, verify cleanliness, and ensure GMP compliance across stages of development and scale-up.

The candidate will manage protocols, support CAPAs, and lead projects that translate to manufacturing readiness.

Qualifications

• B.S. in Science or Engineering with 3+ years of experience; GMP knowledge.
• M.S. in Science or Engineering with 2+ years of experience acceptable.
• Knowledge of regulatory expectations and industry practices related to cleaning.

Responsibilities

• Oversee the clinical equipment Cleaning Program and drive optimizations for eventual commercial transfer.
• Serve as SME on cleaning, including verification methods and carryover calculations.
• Support Cleaning Program activities: lifecycle management, CAPAs, and onboarding.
• Develop and manage protocols, workplans, and templates within the Cleaning Program.
• Lead cleaning-related projects and collaborate with departments on implementation.
• Prepare technical reports and presentations.
• May supervise others as needed.

Skills

Project management

Cross-functional collaboration

GMP knowledge

Communication skills

Analytical thinking

Education

B.S. in Science or Engineering

M.S. in Science or Engineering

Job description

Serán BioScience seeks a Cleaning Validation Engineer III to drive the clinical equipment Cleaning Program and shape its path toward commercial manufacturing. The role partners with cross-functional teams to optimize cleaning methods, verify cleanliness, and ensure GMP compliance across stages of development and scale-up.

The candidate will manage protocols, support CAPAs, and lead projects that translate to manufacturing readiness.