Senior Cleaning Validation Engineer — GMP

Serán Bioscience, LLC; Bend (OR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

PTO accrual

Health benefits

401(k) contribution

Life and disability insurance

Employee assistance program

Pet insurance

Job summary

Serán BioScience in Bend, Oregon, seeks a Cleaning Validation Engineer III to oversee the equipment Cleaning Program, ensuring cleanliness verification and GMP compliance for clinical manufacturing with an eye toward future commercial production.

You will lead cross-functional collaboration, develop protocols, manage projects, and contribute to technical reports while mentoring others as needed; the role offers benefits, PTO accrual, and a progressive retirement plan.

Qualifications

• B.S. or M.S. in science/engineering with relevant experience.
• GMP compliance knowledge and quality systems; at least two years GMP experience.
• Knowledge of regulatory expectations and industry practices related to cleaning.
• Clinical manufacturing experience desirable or relevant pharmaceutical exposure.

Responsibilities

• Oversee the clinical equipment Cleaning Program with minimal guidance and drive optimizations for translation to commercial.
• Serve as SME on cleaning, supporting equipment cleaning and verification methods, carryover calculations, and release procedures.
• Support Cleaning Program activities including lifecycle management, CAPAs, and equipment onboarding.
• Develop and manage protocols, workplans, and templates within the Cleaning Program scope.
• Lead cleaning-related projects, assess changes, and collaborate with impacted departments for implementation.
• Authors and contributes to technical reports and presentations.
• May supervise others and perform duties within supervisory capacity.

Skills

Project management

Strategic thinking

Communication

Collaboration

Time management

Attention to detail

Education

B.S. in Science or Engineering

M.S. in Science or Engineering

Job description

Serán BioScience in Bend, Oregon, seeks a Cleaning Validation Engineer III to oversee the equipment Cleaning Program, ensuring cleanliness verification and GMP compliance for clinical manufacturing with an eye toward future commercial production.

You will lead cross-functional collaboration, develop protocols, manage projects, and contribute to technical reports while mentoring others as needed; the role offers benefits, PTO accrual, and a progressive retirement plan.