Overview
FUJIFILM Diosynth Biotechnologies is a dynamic global company focused on technical leadership in cell culture, microbial fermentation and gene therapies with world-class cGMP manufacturing facilities to advance tomorrow’s medicines. With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the company offers opportunities to move to different roles, relocate, or progress and take on more responsibility. Our teams partner with innovative companies reimagining what’s possible in biopharmaceuticals, with a culture of continuous improvement and evolution.
About Us As a QC IT application system manager you will be responsible for the 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 ensure compliance/alignment between the different requirements at different levels and from different stakeholders of the organization.
Role & Responsibilities
The role includes smaller project management tasks, such as driving upgrade projects, securing operation management, participating as a technical lead in Global IT and compliance projects, initiating and driving own optimization projects (in cooperation with the vendor if required). The role supports maintaining the validated state of the systems throughout the lifecycle. This role requires developing and documenting specialist technical knowledge and transferring knowledge to peers and the business. It also includes acting as the lead site contact to vendors, coordinating system updates, reporting and tracking technical issues, and proactively managing licenses. Other responsibilities include second-level support of the system, maintaining a knowledge base for first-level support, and promoting best practices in application utilization.
What You Will Do
* Provision of timely and effective support to ensure the satisfaction of internal customers. Understand and anticipate needs to enhance quality of service delivery. (10%)
* Ensure the reliability, availability, and security of systems/technologies under your management; stay current with technology and implement system and process improvements. (10%)
* Adhere to ITIL or relevant IT service management (ITSM) frameworks and document/refine IT processes to increase operational efficiency. (15%)
* Compile technology-related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation with relevant IT QMS documentation. (10%)
* Manage or contribute to IT projects, ensuring deadlines and budgets are met; apply best practices in project management. (10%)
* Establish and maintain relationships with technology vendors and service providers; manage vendor performance to ensure value. (10%)
* Oversee day-to-day operations, providing guidance and support to up to 3 direct reports. (10%)
* Foster a collaborative and high-performance culture within the team. (10%)
* Establish KPIs to measure success and drive continuous improvement. (5%)
* Provide regular reports and updates to senior management. (5%)
* All other duties as assigned, including supporting and administering any applications added to the Technical Operations QC IT group portfolio. (5%)
Qualifications And Experience
* Bachelor’s degree in a related discipline (IT or Computer Science) is required.
* 5+ years of experience in IT and/or pharmaceutical industry with knowledge of Computer Systems Validation.
* 5+ years of relevant experience, demonstrating strong leadership capabilities in managing teams and projects.
* Proven experience designing, installing, and testing IT systems.
* Proven experience administering Labware LIMS and Empower applications.
* Pharmaceutical experience is required.
* Proven experience working and/or managing IT projects.
Preferred For The Role
* Additional certifications relevant to the role are desirable (e.g., Labware LIMS or Waters Empower Administration course).
* Experience working in QC and QA processes is an advantage.
Who You Are / Knowledge, Skills And Abilities
* Excellent oral and written communications skills and fluency in English
* Strong analytical skills
* High sense of responsibility
* Working knowledge of software maintenance in a regulated environment. Documented ISO and cGMP understanding and knowledge of GAMP
Why Work With Us
When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition, we offer:
* Competitive salary plus company bonus scheme
* 35 days of holiday, plus bank holidays
* Salary sacrifice scheme including healthcare, bikes, dental, etc.
* Generous pension scheme
* Free parking and electric charging points
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