QC IT Application System Analyst at FUJIFILM Diosynth Biotechnologies

Hillerød, Capital Region of Denmark, Denmark -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

LIMS, Empower, IT Management, Computer Systems Validation, Project Management, Analytical Skills, Problem-Solving, Collaboration, Documentation, GxP, ISO, cGMP, GAMP, Quality Control, Quality Assurance, Technical Knowledge

Industry

Biotechnology Research

Description

Join our Global IT team as a QC IT Application System Analyst! In this role, you will manage and oversee operations and maintenance of the systems in your domain particularly Labware LIMS and Empower. Your expertise will drive continuous improvement in our operational processes, ensuring seamless alignment and compliance across various stakeholder requirements. If you're passionate about optimizing system performance and enhancing organizational efficiency, we want to hear from you! About Us 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. The role In this role 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. 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. This role is currently managing contractors without current line reports but FTE's could be added in the future. Your site location will be our site in Hillerød Denmark reporting to UK based Global Lead - Quality Control IT. Role & 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. Other job duties that may be assigned, including supporting and administering any applications that are added to the Technical Operations QC IT group portfolio. Qualifications and Experience Experience with LIMS and Empower applications management. 5+ years experience in the IT field in the pharmaceutical industry with knowledge of computer systems validation. Experience designing, installing, and testing IT systems. Working knowledge of software maintenance in a regulated environment. Documented ISO and cGMP understanding and knowledge of GAMP Experience in IT projects Experience with QC and QA processes is an advantage Bachelor’s degree in a related discipline (e.g., IT, Computer Science) with a preference for additional certifications relevant to the role. Labware LIMS and/or Waters Empower administration certifications are desired. Skills: Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals Ability to prioritize and work autonomously based on common goals and objectives. Strong analytical mind, eye for detail and problem-solving skills. A natural drive for simplification. Quality minded and strong analytical skills High sense of responsibility and willingness to learn new things Excellent oral and written communications skills and fluency in English How to Apply Apply today by uploading your CV. Applications are screened continuously, so submit yours promptly for consideration. FUJIFILM Diosynth Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines. Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential. Shape the future with us—your drive meets boundless opportunity here https://fujifilmdiosynth.com/ FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class. 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. FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina, Toyama, Japan and College Station, Texas, USA. 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. Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site. We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations. 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. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

Responsibilities

The role involves managing and overseeing the operations and maintenance of Labware LIMS and Empower systems, ensuring compliance and alignment with stakeholder requirements. Additionally, the analyst will provide second-level support, manage vendor relationships, and participate in IT projects.