Lead Cleaning Validation Engineer III - GMP

Seranbio; Bend (OR); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health benefits

PTO accrual

401(k) contribution

Job summary

Serán BioScience in Bend, Oregon is seeking a Cleaning Validation Engineer III to oversee the equipment Cleaning Program, support cleaning and verification of cleanliness, and ensure GMP compliance for clinical manufacturing with an eye toward future scale-up.

You will lead protocols, manage CAPAs, collaborate cross-functionally, and drive improvements in cleaning methodologies, acceptance criteria, and release procedures; strong project management and communication are essential.

Qualifications

• Knowledge of GMP compliance and quality systems.
• Strong verbal and written communication skills.
• Ability to lead cross-functional projects and teams.

Responsibilities

• Oversee the clinical equipment Cleaning Program and drive optimizations for translation to commercial.
• Provide SME support on cleaning methods, carryover calculations, and release procedures.
• Support lifecycle management, CAPAs, and equipment onboarding within the Cleaning Program.
• Develop and manage protocols, workplans, and templates within the Cleaning Program scope.
• Lead cleaning-related projects and collaborate with impacted departments for implementation.

Skills

GMP knowledge

Excellent communication

Cross-functional collaboration

Project management

Education

BS in Science or Engineering

MS in Science or Engineering

Job description

Serán BioScience in Bend, Oregon is seeking a Cleaning Validation Engineer III to oversee the equipment Cleaning Program, support cleaning and verification of cleanliness, and ensure GMP compliance for clinical manufacturing with an eye toward future scale-up.

You will lead protocols, manage CAPAs, collaborate cross-functionally, and drive improvements in cleaning methodologies, acceptance criteria, and release procedures; strong project management and communication are essential.