- Yamagata, Yamagata, Japan
- Full-time · Manager
- 8–12 years
Senior leadership role responsible for directing commissioning, qualification, and validation (CQV) activities across capital projects, facility expansions, equipment installations, and process improvement initiatives in a GMP-regulated manufacturing environment.
Responsibilities
- Lead end-to-end CQV activities for capital projects, facility expansions, equipment installations, and process improvement initiatives.
- Develop and execute CQV strategies aligned with project timelines, quality requirements, and regulatory expectations.
- Establish commissioning and qualification plans covering facilities, utilities, equipment, and computerized systems.
- Manage CQV project schedules, milestones, budgets, resources, and risk assessments.
- Coordinate internal and external CQV resources, including engineering contractors and validation consultants.
Requirements
- Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related discipline.
- Master's degree is advantageous.