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Validation Manager
2 months ago
At FUJIFILM Corporation, we are seeking a highly skilled and experienced Manager, CSV to join our team. This role will be responsible for managing, scheduling, and overseeing all GxP-Regulated Computerized Systems at our manufacturing facilities, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:- Manage and oversee the validation of computerized systems, including DCS, SCADA, and BMS systems
- Develop and implement validation plans, protocols, and reports
- Ensure compliance with regulatory requirements, including 21 CFR Part 11, Annex 11, and GAMP5
- Supervise and manage a team of validation engineers and specialists
- Collaborate with cross-functional teams to ensure effective validation and compliance
- Master's degree in a relevant field, such as engineering or science, and 5+ years of experience in computer systems validation
- Proven experience in managing and overseeing validation activities, including development and implementation of validation plans and protocols
- Strong knowledge of regulatory requirements, including 21 CFR Part 11, Annex 11, and GAMP5
- Excellent communication and leadership skills
- Ability to work in a fast-paced environment and prioritize multiple tasks and projects
- A competitive salary and benefits package
- Opportunities for professional growth and development
- A dynamic and collaborative work environment
- Recognition and rewards for outstanding performance
We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.