Junior QC IT Systems Analyst

Overview

FUJIFILM Diosynth Biotechnologies (FDB) is growing its capabilities and seeking talented, mission-driven people who want to make a real difference in people’s lives. Join FDB to help create the next vaccine, cure, or gene therapy in partnership with innovative biopharma companies globally. You’ll work alongside and learn from dedicated scientists, engineers, and manufacturers, in a culture that fuels passion, energy, and drive. This is what FDB calls Genki.

Join us to discover a community that thrives on diversity and tackles complex challenges. At FDB, you determine what’s possible.

About Us

We are a dynamic global company focused on technical leadership in cell culture, microbial fermentation and gene therapies, combined with world-class cGMP manufacturing facilities to advance tomorrow’s medicines.

With sites in Billingham & Wilton UK, Hillerød Denmark, North Carolina and Texas USA, the size and breadth of our business open up opportunities to move to a different role, relocate, or progress and take on more responsibility.

Our teams partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.

Role & Responsibilities

As a Junior QC IT Systems Analyst you will be responsible for operations and maintenance of the systems in your domain, particularly Labware LIMS and Empower. Your key objective will be to continuously improve business operations and to ensure compliance/alignment between the different requirements at different levels and from different stakeholders of the organization.

You will work with the vendors and help coordinate all updates to the systems, report and track technical issues, proactively manage licenses of the systems, as well as providing second level support of the system, maintaining a knowledge base for first level support as well as promoting best practices in the application utilization.

The role also includes smaller project management tasks including supporting upgrade projects, operations management, participating as a subject matter expert in Global IT and compliance projects, initiating and driving own improvements in cooperation with vendors if required. You would be responsible for supporting the maintenance of the validated state of the systems throughout the life cycle. This role requires developing and documenting the technical knowledge and transferring technical knowledge to peers and the business.

Key Responsibilities

• Provision of timely and effective support to ensure the satisfaction of internal customers. Understand and anticipate the needs to enhance the quality-of-service delivery.
• Responsible for ensuring the reliability, availability, and security of systems/technologies under your management. Keeping up to date with technological advancements and implementing system and process improvements in your area
• Adherence to ITIL or relevant IT service management (ITSM) frameworks is expected, along with the responsibility for documenting and refining IT processes to increase operational efficiency and effectiveness.
• Compile technology related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation together with relevant IT QMS documentation
• Manage or contribute to IT projects, ensuring they meet deadlines and stay within budget. Employing best practices in project management
• Establishing and maintaining relationships with technology vendors and service providers. Managing vendor performance to ensure the company receives value from them.
• Support and administer any applications that are added to the Technical Operations QC IT group portfolio
• And other job duties that may be assigned from time to time.

Knowledge & Skills

• Excellent oral and written communications skills and fluency in English
• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
• Pharmaceutical experience is required
• Ability to prioritize and work autonomously based on common goals and objectives.
• You have a strong analytical mind, eye for detail and problem-solving skills. You have a natural drive for simplification.
• Quality minded
• Strong analytical skills
• High sense of responsibility.
• Willingness to learn new things
• Experience with QC and QA processes is an advantage
• Working knowledge of software maintenance in a regulated environment. Documented ISO and cGMP understanding and knowledge of GAMP
• Experience in IT projects

Qualifications and Experience

Qualifications and Experience

• Bachelor’s degree in a related discipline (e.g. IT or computer science)
• Additional certifications relevant to the role are desirable (for example Labware LIMS or Waters Empower Administration course completion).
• 2+ years experience in the IT field and/or pharmaceutical industry with knowledge of computer systems validation.
• Experience designing, installing, and testing IT systems.
• Experience administering Labware LIMS and Empower applications.

Why work with us?

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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.