Position Overview

Simplicity and agility are important in everything we do. We are delivering world class IT support by providing the correct IT solution in a timely and user aligned manner - for us, this is of critical importance. As an IT Validation Engineer, you will be part of the Information Security Office domain within the Business Technology & Digital Solutions department. You will work together with other highly dedicated and skilled colleagues focused on the mission of ensuring stable, efficient, and compliant validation services.​  

Company Overview

The work we do at FUJIFILM Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki.  Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

In this role you will be responsible for providing validation support to numerous projects across the FUJIFILM Biotechnologies (FLB) network, whilst driving continuous improvement of IT procedures and processes.

Principal Accountabilities:

• Prepare, plan and execute validation tasks to support Digital Technologies. Guide contractor CSV resources where applicable.
• Support the global organization and computerized system validation team on compliance and regulatory expectations and inspections and customer audits.
• Define global CSV standards alongside global stakeholders while identifying and implementing CSV related improvements within the organization and within the IT quality management system.
• Contribute to the continuous development of our processes and tools by contributing knowledge and experience within the validation domain.
• Identify, assess, and mitigate risks with escalation of high residual risks.
• Ensure control with various compliance activities (e.g., no overdue training or site actions).
• Train and coach personnel in the application of computerized system validation principles.
• Build and maintain good working relationships with key stakeholder functions from any of the FLB sites.
• Support the business in the delivery of key objectives and priorities.
• Ensure all regulatory, agency, customer, and internal audit learnings related to computerized system validation are implemented across the business.

Minimum Education and Experience Required:

• Bachelor’s Degree in Engineering, Computer Science or similar.
• 5+ years industry relevant experience in related area within the Pharmaceutical Industry.
• Experience with GMP, IT projects, GAMP, ISO and cGMP understanding.
• Any combination of education and experience, which would provide an equivalent background to deliver against role expectations.  

Knowledge, Skills and Abilities:

• The role must have knowledge of regulatory requirements and expectations.
• Quality minded
• Strong analytical skills and problem-solving skills, with high attention to detail.
• Excellent communication and interpersonal skills.
• Strong networking abilities.
• Ability to present complex information to a variety of audiences.
• High sense of responsibility.
• Knowledge of regulatory compliance to align with cGMP and other regulatory requirements.

This is a global position that will support all our FUJIFILM Biotechnologies sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organization is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fdbglobaltalent@fujifilm.com).