As a QC IT Application System 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 be the lead site contact to the vendors and responsible for coordinating all updates to the systems, report and track technical issues, proactively manage licenses of the systems.  

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow’s medicines – our Genki – will always be our driving force. Whilst working as a Senior QC IT System Analyst on our IT team, you’ll be joining other motivated individuals who fuel one another’s passions and embrace every day as an opportunity. We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package. 

You will be responsible for second level support of the system, maintain a knowledge base for first level support as well as promote best practices in the applications utilization.  

The role also includes smaller project management tasks, like driving upgrade projects and secure operation management is considered, participate as a technical lead in Global IT and compliance projects, initiate and drive own optimization projects, in cooperation with vendor if required.  

The role supports the maintaining of the validated state of the systems throughout the life cycle. This role requires developing and documenting the specialist technical knowledge and transferring technical knowledge to peers and the business.​ 

Principal Accountabilities and Main 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. (15%)
• 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  (15%)
• 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. (20%)
• 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 (20%)
• Manage or contribute to IT projects, ensuring they meet deadlines and stay within budget. Employing best practices in project management (15%)
• Establishing and maintaining relationships with technology vendors and service providers.   Managing vendor performance to ensure the company receives value from them. (15%)
• Other job duties that may be assigned, including supporting and administering any applications that are added to the Technical Operatoins QC IT group portfolio.

Minimum Education and Experience Requirements:

• Bachelor’s degree in a related discipline (e.g., IT, Computer Science) with a preference for additional certifications relevant to the role.  

• 5+ 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.  

• Labware LIMS and/or Waters Empower administration certifications are desired.

Knowledge and 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  

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark; Teesside, UK; RTP, North Carolina; Holly Springs, North Carolina; College Station, Texas; and Thousand Oaks, California. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.