Job Details
Posted 1 May, 2026
Job Id: 627646
Senior Sterilization Validation/Cleaning Validation
Job Description
Job Title: Senior Sterilization Validation / Cleaning Validation SME
Location: Japan (Onsite)
Overview
We are supporting a global pharmaceutical organisation on a high-impact opportunity for a Senior Sterilization Validation / Cleaning Validation SME to be based onsite in Japan. This is a key role within a GMP-regulated manufacturing environment, offering the chance to take ownership of critical validation activities and influence validation strategy at site level. You will work closely with senior stakeholders, acting as a subject matter expert and playing a central role in ensuring inspection readiness and compliance. This position is well suited to someone looking to step into a visible, hands-on SME role, with real influence over validation standards, processes, and continuous improvement initiatives.
Key Responsibilities:
- Lead sterilization and cleaning validation activities across the full lifecycle
- Define validation strategies and ensure alignment with global GMP standards
- Prepare and review validation documentation (IQ/OQ/PQ, protocols, reports)
- Manage revalidation, deviation handling, and change control
- Provide SME-level guidance to client teams and stakeholders
- Support audits and regulatory inspections as a technical expert
- Ensure data integrity and compliance with ALCOA+ principles
- Drive improvements in validation and contamination control strategies
Requirements:
- 8-12+ years of experience in sterilization and/or cleaning validation
- Strong expertise in GMP and validation lifecycle management
- Proven experience in pharmaceutical or biotech manufacturing environments
- Experience with plasma-derived products is highly desirable
- Deep knowledge of sterilization methods (moist heat, dry heat, filtration)
- Strong background in cleaning validation (limits, worst-case, sampling techniques)
- Ability to work autonomously and interact with senior stakeholders
Languages
- Fluent Japanese (mandatory)
- Business-level English (strongly preferred)
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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